The lead wires in question have been used in Medtronic’s implantable cardioverter defibrillators and cardiac resynchronization therapy-defibrillators since 2004, and can be found in nearly all such cardiac devices, though not in conventional pacemakers. It is estimated that between 235,000 and 270,000 patients have had these ICD's implanted. The following are the four lead wire models recalled by Medtronic:
- Sprint Fidelis 6930
- Sprint Fidelis 6931
- Sprint Fidelis 6948
- Sprint Fidelis 6949
While these are the only four lead models to have been officially recalled, it is important to know that the faulty leads have been used in other manufacturers' defibrillators.
As such, the first step as a concerned patient should be to find out what lead wire model your ICD/CRT-D uses, and contact our offices immediately at (866) 445-9599.
The Medtronic recall announced on October 15, 2007, effectively halted sales on the four lead wire models mentioned above, and required that all unused inventory be returned to the company. However, at this time neither Medtronic nor the FDA is advising that patients with the implanted devices have the lead wires removed, as this procedure could be even riskier than the surgery required to remove the device entirely. They advocate that physicians reprogram the device to minimize problems, and to alert patients earlier in the event of a lead wire fracture, so that they may seek medical attention before an adverse event occurs.
If you or a loved one has experienced any of the three adverse events under our “What to Watch For” tab, or if you or a loved one has a recalled Medtronic defibrillator lead wire model implanted, you should consult with a healthcare provider immediately, as you may be at risk for increased heart problems.
According to Medtronic's own research, a lead can fracture as much as 30 months after being imlpanted - so even if you have not yet experienced an adverse event, for your future health and safety, you should still consult with an attorney TODAY.
You may also have rights to compensation. We encourage you to inform yourself of the dangers associated with certain lead wires in ICDs by taking a look around our site. We also encourage you to fill out an inquiry form so that we may contact you to discuss your potential claim and the litigation surrounding this potentially life-threatening device.
You can also contact our firm directly and speak with an attorney today. Our legal and medical experts can be reached by calling (866) 445-9599, by writing to info@douglasandlondon.com, or by completing our Free Case Evaluation Form and letting someone from our office contact you.
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