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Friday, September 23, 2005 |
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Wednesday, September 21, 2005 |
FDA Preliminary Public Health Notification*: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
Date: July 14, 2005
This is to provide clinicians with current information and guidance concerning malfunctions occurring with Guidant’s PRIZM® 2 and CONTAK RENEWAL® implantable cardioverter defibrillator (ICD) devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005.
The affected devices are:
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| Guidant Pacemaker |
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CONTAK TR Model 1241 |
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DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286 |
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DISCOVERY Models 1174, 1175, 1273, 1274, 1275 |
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Guidant Class Action |
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Guidant Pacemaker Recall |
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INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499 |
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MERIDIAN Models 0476, 0976, 1176, 1276 |
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Pacemaker Recall |
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PULSAR MAX II Models 1180, 1181, 1280 |
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PULSAR MAX Models 1170, 1171, 1270 |
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PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272 |
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VIRTUS PLUS II Models 1380, 1480 |
The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. At this time it is not possible to provide accurate estimates of the failure rate for these devices, but at least two deaths attributable to this failure mode have been reported.
Recommendations:
If this failure mode is demonstrated to have occurred, the device should be replaced. However, the FDA is not making a recommendation on whether patients who have one of these devices should have it replaced under other circumstances. We believe that this decision must be made by the patient in consultation with his or her physician, and should be based on the patient’s condition, medical history, and other pertinent factors.
We recommend that you:
- Contact each of your patients affected by the recall, and advise coming in for an evaluation if he or she has not been seen recently. Discuss with the patient the factors that will enter into the decision regarding replacement, including medical history, the risks of replacement, device battery status, and the likelihood that this patient will require the defibrillation or pacing features of the device in the future. You may wish to provide a copy of FDA’s “Advice to Patients with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators” http://www.fda.gov/cdrh/medicaldevicesafety/atp/071405-guidant.html to your patients.
If the device is to be left in place, advise patients to:
• continue with their regularly-scheduled follow-up appointments;
• contact you as soon as possible if they receive a shock from the device;
• go immediately to your office or clinic, or to an emergency room, if they hear a “beeping” noise coming from the ICD, because this may mean that the device is damaged.
- Verify normal device function at every patient visit, using routine clinical follow-up procedures.
• If a shock was delivered since the prior follow-up visit, check for out-of-range values in the “Last Delivered Shock” impedance as stored in the device’s memory.
• Follow the manufacturer’s instructions for evaluating warning screens encountered during interrogation of the patient’s device.
• Also check for other indicators of device malfunction, including loss of the telemetry, programming, or interrogation functions, loss of tachyarrhthmia detection and therapy, and a decrease in pacing output.
- In order to better characterize the failure rate, it is essential that you return all explanted devices to the manufacturer for analysis, regardless of the reason for explant. All returned devices, including those that are still functional at the time of explant, are analyzed by the company to better understand their performance. In the case of patients who die with an implant, we strongly encourage interrogation and, if possible, explantation and return of the ICD.
- Because there are no signs of impending device failure, and there is no test that predicts whether any particular device will fail, FDA has concluded that there is insufficient evidence at this time to support the value of a commanded shock.
Failure Mode Information
Guidant’s laboratory analysis has determined that a breach in insulation surrounding a high voltage wire within the lead connector block, in conjunction with other circumstances, can allow undesirable shunting of energy to the active titanium case during shock delivery. Diversion of energy away from heart tissue may trigger a programmer screen message upon next interrogation, warning clinicians that full energy was not delivered to the heart during the last shock delivered. If sufficient shock energy is diverted to internal circuitry, it may render the device inoperative, preventing telemetry and delivery of additional shock therapy or bradycardia pacing. Bench testing has shown that the number of shocks delivered does not affect the likelihood of device failure.
In some of the malfunctioning devices investigated by Guidant, a yellow programmer warning screen describing low shock lead impedance or a shorted shocking lead condition was observed upon programmer interrogation post-shock. In each case, clinical evaluation of the lead system did not confirm a lead issue and for this reason each device was explanted and returned to Guidant for analysis. In some of the other cases, the yellow screen did not appear, as circuitry damage prevented programmer telemetry.
In some of the cases, a problem was identified during in-clinic cardioversion for atrial fibrillation. In the remaining cases, patients were away from the clinic, but a warning screen or loss of telemetry was observed when the patient returned to the clinic immediately following shock delivery or for a scheduled office visit.
Reporting Adverse Events to FDA
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of a Guidant ICD, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA’s understanding of and ability to communicate the risks associated with devices and assist in the identification of potential future problems.
3:22:12 PM 
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Thursday, June 09, 2005 |
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Tuesday, June 07, 2005 |
Social Security Disability Information
Your source for Social Security Disability Benefits information
All to often, The Social Security Administration (SSA) wrongfully denies Social Security Disability Benefits to truly disabled claimants. Congress has defined "disabled" as:
The inability to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted or can be expected to last for a continuous period of no less than twelve months.
For a claimant to be determined "disabled" under disability he or she must have physical or mental impairments to the extent that the severity is to such a great degree that he or she is unable to return to their previous employer due to the fact that they can not perform their pre-injury work place tasks. Generally, the claimant must also have one of the listed Social Security physical or mental impairments.
We are The Social Security Law Group and we have designed this web site to offer you useful Social Security resources and assistance in obtaining SSDI benefits. We are a private law firm (not affiliated with SSA nor any other Federal or State Agency) practicing nationwide exclusively in the area of Social Security Disability Law. We have dedicated our professional careers to ensuring that eligible disabled claimants who have been wrongfully denied Title II Social Secuirty Disability (SSDI) receive the benefits they rightfully deserve. If you have questions regarding your claim or potential eligibility, please feel free to contact us using our free case evaluation form. Please remember, we are currently assisting only those claimaints who are eligible for Title II SSDI benefits.
Every inquiry we receive is carefully evaluated by one of our experienced SSDI attorneys. We will offer you a free, no obligation evaluation of your Social Security Claim and contact you directly to discuss any additional issues. You can take advantage of this free service by clicking on the Free Case Evaluation button above. Studies show that a 20-year-old worker has a 3-in-10 chance of becoming disabled before reaching his or her retirement age.
The Social Security Law Group provides ethical, professional, legal advocacy and has extensive experience in Social Security Disability Law. We provide quality legal administrative support to claimants who are disabled and are no longer able to work. We guide and support them with attorney representation in their pursuit of Social Security benefits at all levels of the Social Security Administrative and Judicial process.
What’s the difference between SSI and SSDI?
The difference is significant. Below is a brief description of each program and how it works.
SSDI - This is known as Title II (2) Social Security Disability Benefits. This program is for people who have made sufficient FICA (Federal Insurance Contribution Act) contributions in the last 5 years. We have listed below the minimum amounts of earnings in 2003 to qualify for Title II Disability Benefits.
| Year |
Amount Per Quarter |
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Amount Per Year |
| 2003 |
$890.00 |
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$3,480.00 |
For Example: if in 2003, you earned at least $890.00 of gross wages (wages which you or your employer reported and paid FICA taxes), you would have paid for 1 quarter of SSDI coverage. If you earn $3,480.00 in 2003 you are covered for the entire year (4 Quarters). Remember, you need to pay 20 of the last 40 quarters to be eligible for SSDI benefits. Below is the coverage amounts for years 2002 through 1994.
| Year |
Amount Per Quarter |
Amount Per Year |
| 2002 |
$870.00 |
$3,480.00 |
| 2001 |
$830.00 |
$3,320.00 |
| 2000 |
$780.00 |
$3,120.00 |
| 1999 |
$740.00 |
$2,960.00 |
| 1998 |
$700.00 |
$2,800.00 |
| 1997 |
$670.00 |
$2,680.00 |
| 1996 |
$640.00 |
$2,560.00 |
| 1995 |
$630.00 |
$2,520.00 |
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1994 |
$620.00 |
$2,480.00 |
If you qualify for SSDI benefits, you must file an application and be deemed medically disabled under SSA’s rules. Once you are approved, you need not worry about other sources of income such as rental income, stocks bonds, etc. Once you start to earn income from “work” or “Substantial Gainful Activity” as SSA deems it, then these earnings are monitored for purposes of a trial work period. (see this section of our web site for details)
If you qualify for SSDI benefits, THE SOCIAL SECURITY LAW GROUP® can assist you in your application or appeal.
SSI—This is known as Title XVI (16) Supplemental Security Income. This program is for people who either:
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Have not paid enough quarters (earnings) into Social Security for any reason.
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You must have paid into Social Security through wage and FICA contributions for 20 out of the last 40 quarters.
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b. If you are unsure, please read the instructions below as to how to confirm if you have paid enough into SSDI.
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Have limited resources and income
Although you must be disabled according to SSA’s definition, you must first meet SSA’s strict resource eligibility test prior to your medical condition being considered. If your resources exceed SSA’s limit, you cannot collect SSI irrespective of your medical disability.
Once you are approved, all your other sources of income will be monitored by SSA to ensure that you continually meet their strict resource requirements. THE SOCIAL SECURITY LAW GROUP® is presently not assisting claimant’s in SSI claims.
What if I am not sure if I qualify for SSI or SSDI?
Some of the people who visit our site and contact us are unsure if they are Title II eligible. You are encouraged to contact SSA to verify your eligibility for Title II. To do so, please follow the instructions below:
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Call the SSA national Toll Free line at 800-772-1213
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Follow the prompts to speak with a representative
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Tell the representative you want to file a Disability claim, and you need to know if you are Title 2 or Title 16 eligible. If they tell you that you are Title 2 eligible, please ask them:
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What is my DATE LAST INSURED?
6:21:54 PM
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Thursday, May 26, 2005 |
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Thursday, May 12, 2005 |
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VIOXX LINKED TO HEART ATTACK AND STROKE
Vioxx, a widely used prescription medicine produced by drug manufacturing giant, Merck & Co., was voluntarily withdrawn on September 30, 2004 due to mounting evidence linking it to increased risk of cardiovascular problems. Following a three-year study involving the drug, researchers concluded that withdrawing Vioxx from the market would be in the best interest of the patients. The drug, a popular pain reliever used worldwide by millions of patients, has also been connected with higher incidences of respiratory and liver and kidney dysfunction.
NEWS: 11-10-04 - BEXTRA MORE THAN DOUBLES RISK OF HEART ATTACK - This week, researchers said a preliminary study indicated that Bextra, a painkiller in the same class as Vioxx, more than doubled the risk of heart attack. Bextra has also been linked to strokes, heart disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Click Here for more information regarding Bextra.
Vioxx is classified as a COX-2 inhibitor, a type of drug deemed to be safer for the gastrointestinal system than nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, the cardiovascular safety of this drug family has come under enormous scrutiny of late. Studies have shown that individuals taking Vioxx have between a 17 and 24 percent increase in heart attack risk compared to individuals taking comparable pain relief drugs on the market.[1]
Vioxx is used extensively for the treatment of many types of pain. While most commonly used to treat arthritis-related pain in its various forms, there are a number of other uses for the drug:
- Relief of pain and inflammation of osteoarthritis (arthritis from wear and tear on your bones and your joints)
- Relief of pain and inflammation of rheumatoid arthritis in adults (arthritis caused by a condition where your immune system attacks your joints)
- Management of short-term pain
- Treatment of menstrual pain (pain during women’s monthly periods)
- Treatment of migraine headache attacks with or without aura.[2]
Vioxx has been linked to serious cardiovascular events, including heart attacks and strokes. If you or someone you love has been injured as a result of taking the drug Vioxx, you may be entitled to monetary compensation. For a free review of your claim, please fill our Vioxx Free Consultation form. Upon submission, your free consultation form will be sent to the sponsored personal injury lawyer for evaluation. That lawyer will personally evaluate your case, and may contact you to further discuss your situation, and/or attempt to refer you to a qualified lawyer who may be able to assist you. Please be advised that by submitting a free consultation form, you are not entering into an attorney client relationship with the individual firm or lawyer.
[1] www.healthfinder.gov/news/newsstory.asp?docID=518497
[2] Patient Information about Vioxx | | |
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8:37:57 PM
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Monday, May 09, 2005 |
Case Specific Resources and Free Legal Consultations
Black=Free Legal Consultation
Red=Government, Medical Website or Third Party Sources
- Acquired Brain Injury Free Attorney Consultation- brain condition that occurs due to prolonged contact or intake of toxic substances.
- Airplane Accidents Free Attorney Consultation- in the United States alone over 200 people die per year in airplane crashes.
- Amusement Park Accidents Free Attorney Consultation- in the year 2000 alone over 10,580 injuries that required ER treatment were reported due to mechanical amusement park rides alone.
- Park Product Liability
- Operator Neglect
- Wreckless Endangerment
- See Government Amusement Park Statistics From 2001
- Auto Accidents Free Attorney Consultation- In 2002, 42,815 people were killed in the estimated 6,316,000 policereported motor vehicle traffic crashes, 2,926,000 people were injured.
- Birth Injury Free Attorney Consultation- "Impairment of the infant’s body function or structure due to adverse influences that occurred at birth." In the year 2002 there were 3,623,893 birth injuries reported."
- Brain Damage Free Attorney Consultation - can be the result of a sudden traumatic experience or can be the result of prolonged exposure to harmful or toxic materials. Also occurs due to a lack of oxygen.
- Car Accidents Free Attorney Consultation- NHTSA estimates that alcohol was involved in 41 percent of fatal crashes and in 6 percent of all crashes in 2002. The 17,419 fatalities in alcohol-related crashes during 2002 represent an average of one alcohol-related fatality every 30 minutes.
- Cerebral Palsy Free Attorney Consultation- "a group of disorders that affect a person's ability to move and to maintain balance and posture due to a nonprogressive brain abnormality, which means that it does not get worse over time. However, the exact symptoms can change over a person's lifetime."(CDC)
- Coma Free Attorney Consultation- "A coma is a profound or deep state of unconsciousness. An individual in a state of coma is alive but unable to move or respond to his or her environment. Coma may occur as a complication of an underlying illness, or as a result of injuries, such as head trauma."
- Coma
- Workrelated or Work Place Injury
- Workers Compensation and Disability Benefits
- See Governmnet Coma Information and Resource Page
- Construction Accidents Free Attorney Consultation- "You have a right to a safe and healthful workplace. That's why Congress passed the Occupational Safety and Health Act of 1970, requiring employers to provide workplaces free from serious recognized hazards..."
- Defective Products Free Attorney Consultation- The U.S. Consumer Product Safety Commission (CPSC) has jurisdiction over more than 15,000 kinds of consumer products.
- Defective Products: Cars, Boats, Foods, Medicines and Environmental Products
- Product Liability
- Defective Product Class Actions
- See Government Site for a Database of Defective Products and Recall Products
- Elder Abuse Free Attorney Consultation- "Each year hundreds of thousands of older persons are abused, neglected and exploited by family members and others. Many victims are people who are older, frail, and vulnerable and cannot help themselves."
- 551,011 persons, aged 60 and over, experienced abuse, neglect in a one year period.
- Elder Neglect Claims
- Nursing Home Abuse
- See Government Site for Elder Abuse Information and Elder Assistance Resources
- Erbs Palsy Free Attorney Consultation- a condition that occurs due to breech births, prolonged births or other situations where the Doctors believe they are required to remove the infant with some measure of force that can lead to Brachial Plexus Injuries.
- Failure to Diagnose Free Attorney Consultation- delay in the diagnostic process can allow for cancer metastisis, corroded arteries to devolop into a stroke and in serious cases can be the direct cause of a preventable death.
- Fatal Accidents Free Attorney Consultation- in the year 2002 alone there were 5524 workplace fatalities reported to the Government. From 1992 to 2002 there were 67,363 work related deaths reported to the government.
- Head Injury Free Attorney Consultation- "A blow or jolt to the head can disrupt the normal function of the brain. Doctors often call this type of brain injury a 'concussion' or a 'closed head injury.' Doctors may describe these injuries as “mild” because concussions are usually not life threatening. Even so, the effects of a concussion can be serious."
- Head Injuries: TBI ABI
- Shaken Baby Syndrome
- Workplace or Construction Realted Accident
- See Government Site for Infomation, Resources and Symptoms of Head Injuries
- Medical Malpractice / Medical Error- "A recent report by the Institute of Medicine estimates that as many as 44,000 to 98,000 people die in U.S. hospitals each year as the result of medical errors. This means that more people die from medical errors than from motor vehicle accidents, breast cancer, or AIDS."
Mesothelioma Free Attorney Consultation- "Mesothelioma is a rare form of cancer in which malignant (cancerous) cells are found in the mesothelium, a protective sac that covers most of the body's internal organs. Most people who develop mesothelioma have worked on jobs where they inhaled asbestos particles."
Motorcycle Accident Free Attorney Consultation- "In 2001, 3,181 motorcyclists were killed and an additional 60,000 were, injured in traffic crashes in the United States..."
Negligent Security Cases Free Attorney Consultation- When a known unsafe condition is not addressed and is allowed to persist, putting consumers, neighbors and workers in harms way damages thousands of people each year.
- Negligent Securities
- Slip and Fall Accidents
- Workers Compensation and Lost Wage Restitution
- See Government Site for Workplace Negligent Securites Information and Resources
Nursing Home Abuse Free Attorney Consultation- "About 1.6 million elderly and disabled Americans receive care in nearly 17,000 nu | |
