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Product Liability

Posted by: euser
November 16, 2006
Topic: Personal Injury / Car Accidents / Wrongful Death

A scary story involving a problematic pacemaker.   Prior to a major surgical procedure, it pays to ask questions.  Unfortunately, in life-threatening situations, people don't always have time to do just that. 

If you have questions regarding medical device implants / problems, please call Bush & Powers for a free initial consultion.  704-342-4357. 

Here is the article: 

Zina Lewis, 39, is a nurse in Park City, Utah, where she and her husband, Bruce, are starting a family. Zina has had a heart device of some type ever since complications from viral pneumonia set in, during her teens. In 2002, Zina had a Guidant Pulsar Max II dual chamber pacemaker implanted. Throughout 2002 and 2003, her health inexplicably deteriorated (edema, tachycardia episodes, fevers, frequent dizziness, presyncopal episodes and general discomfort in her chest). By July 2003, Zina's doctors urged her to have the device removed. After undergoing a complex open-heart surgery to have it removed, Zina received another Guidant implant device – the Insignia pacemaker.
 

Prior to undergoing this life-threatening surgery, Zina was never notified that between May and June 2003, Guidant, with the FDA's knowledge, issued safety advisories for both the Insignia and Pulsar Max II. Zina would never have received the Insignia implant had she been aware of the advisory, nor would she have waited to have the also-faulty Pulsar Max II removed. The Insignia was a faulty device that Zina lived with until several complications required its removal in 2004 – the same year that Guidant, with the FDA's knowledge, issued a recall of both the devices. Not only did both devices not help her problems, they actually exacerbated her already-fragile longstanding condition.

Zina, and the hundreds of other individuals implanted with the faulty devices, were never notified of the recalls. This haphazard process left Zina not only with immense physical and emotional trauma but also a future plagued with life-threatening medical complications, including a compromised right heart valve, unnecessary medication, increased risk of necessary future open-heart surgeries, and most importantly to her budding family, her inability to have children. With such critically important equipment, a standardized identification system  – as well as an FDA policy to better notify patients – would greatly improve patient safety.

 

In the Agency 

 The FDA is the federal agency responsible for regulating medical devices. As part of its duties, the FDA is charged with ensuring that unsafe medical devices are properly recalled and removed from the market. However, at the present time, a uniform method to track medical devices does not exist. In the context of a recall, the inability to effectively and quickly identify the devices can produce serious or even grave consequences for individuals like Zina Lewis.  Placing a unique device identifier, or a specialized identification code, on all medical devices can substantially improve the recall process by providing for a simple way to quickly and effectively identify the defective devices and notify consumers.  The FDA recently invited comments regarding the possible adoption of regulations to require medical devices to contain unique device identifiers. ATLA submitted comments in favor of adopting mandatory unique device identifiers for medical devices and sees the FDA's interest in the topic as a positive initiative toward improving patient safety. By the Numbers

8,000: Approximate number of new medical devices marketed in the U.S. each year

200,000: Approximate number of "adverse event reports" received by the FDA's Center
for Devices and Radiological Health each year

1,000: Approximate number of medical devices recalled every year

In the News

FDA proposes tracking devices
St. Paul Pioneer Press, 11/10/2006
"The U.S. Food and Drug Administration on Thursday released a proposal for improving detection and reporting of problems once pacemakers, implantable cardiac defibrillators and thousands of other medical devices are on the market and being used by patients. The recommendations come after more than a year of introspection within the FDA, the heart-device industry and the medical community that began with a series of recalls involving heart devices made in the Twin Cities."

Patients Frustrated Over Pacemaker Recall
KSL-TV, 9/30/05
"While the Senate Finance Committee and the FDA continues investigating a major manufacturer of heart pacemakers, frustrated patients say they're still not getting all they need to know about the recall. Some patients are saying this "NOT KNOWING" is appalling. You don't have to look very far in any community to see how many people - like Chris Moore here - have implanted pacemakers or defibrillators to safeguard their hearts to keep them in rhythm."



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