|MEDTRONIC INJURIES & WARNINGS
- If a lead breaks, it can cause life-threatening injuries
- Medtronic recalled the defective leads on October 15, 2007
- Medtronic should have discovered the defect and issued warnings earlier
INJURIES FROM THE DEFECTIVE LEADS
There are more than 268,000 people worldwide who have the recalled leads implanted. According to the FDA, so far, less than 1% of these leads have actually broken. Whether or not the leads become more prone to break as they become older remains to be seen.
If a lead breaks, it can cause the defibrillator to shock the person when they don’t need it or it may fail to operate at all when they do need it. A malfunctioning defibrillator is life-threatening.
According to Medtronic, five patient deaths have been attributed to the defective leads so far. The FDA has confirmed that “… some deaths and major complications have occurred after the leads have fractured.”
Regardless of the number of physical injuries, all 268,000 patients have suffered injury from using this product. Each one of these patients is walking around today knowing that they have a device inside their chest that may kill them at any moment and, for many of them, there’s nothing they can do about it.
If you or someone you know has a recalled lead implanted, please contact our firm for a free consultation with one of our pharmaceutical attorneys.
WARNINGS ISSUED
On October 15, 2007, an FDA press release was issued to announce a recall of certain models of Sprint Fidelis defibrillator leads.
Medtronic, Inc., the company that makes the leads, sent a “Dear Doctor letter” to healthcare professionals the same day. In attachments to the letter, they included among other things, performance data on the recalled leads, advice on how to manage patients with defective leads implanted, and the risks of lead removal.
Medtronic is requesting that the recalled leads be pulled from inventory and returned to the company. As for the leads already implanted, there are three options: Surgically remove the defective lead; leave the defective lead in and closely monitor for problems; or add a replacement lead, leaving the defective lead in, but capping it so that it is no longer in use. Medtronic and the FDA are advising against the routine surgical removal of the leads, and instead, suggest using one of the other two options.
FAILURE TO WARN
Medtronic has notified the public and removed these defective leads from the market. But these warnings come too late for the 268,000 people who now have defective leads implanted in their chests.
The leads in question went on the market in September 2004. By March 2007, the FDA was receiving reports of lead fractures. The number of fractures wasn’t higher than with other leads, but the location of the fractures was unusual.
After 6 months of follow-up, Medtronic decided to issue warnings and pull the Sprint Fidelis leads from the market. It will no longer make or sell these particular models.
The question is ... Did Medtronic know about the defect before March 2007? Should they have known? Medical technology companies have a duty to test their products before they go on the market and to conduct extensive post-marketing research. Unfortunately, many companies place their own profits above patient safety and introduce products prematurely, causing tragic losses that could have been avoided.
At the Law Offices of Howard L. Nations, we represent people who have been injured by defective drugs and medical devices.
If you or someone you know has a recalled Medtronic lead implant, contact our offices for a free case review by one of our experienced pharmaceutical lawyers.
The Nations Law Firm | A National Pharmaceutical Litigation Firm
4515 Yoakum Boulevard | Houston, TX 77006-5895 | Telephone: 713-807-8400 / Toll Free: 1-800-269-3050 | FAX: 713-807-8423
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