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Home > Medical Devices
Medtronic Sprint Fidelis Defibrillator Lead Recall
In Denver, Colorado and Nationwide
On October 15, 2007 Medtronic announced that it was voluntarily suspending sales of its Sprint Fidelis implantable cardioverter-defibrillator (ICD) leads because these leads could break, leading to:
- A warning beep from the ICD
- Serious repeated "inappropriate" electrical shocks
- Failure of the unit to deliver electric shocks as promised
On the same day, the FDA announced a Class 1 recall on the devices, an action that implies that there is a reasonable possibility that use of the product could lead to serious injury or death. Affected model numbers are 6930,6931, 6948, and 6949.
This is in addition to, and unrelated to, the recall of Medtronic defibrillators announced in 2004.
However, due to the risk involved in removal of the ICD leads, neither the FDA nor Medtronic are recommending the removal of Spring Fidelis leads. The surgery to remove the leads is more dangerous than the likelihood that life-threatening complications will arise from lead failure.
Medtronic assures doctors and patients that this is so. According to their studies, the expected failure rate is only 2.3 % at 30 months from the date of implantation, although it is expected to increase. Medtronic gives additional assurance to clients and physicians by stating that 90% of the failures occur in such a way that patients will be warned of the failure, either through the beeping of the ICD or through the "inappropriate" electric shocks, which, although highly painful, are not generally life-threatening.
But there is reason to doubt at least one portion of this claim. Medtronic is basing its 90% failure-with-warning figure on its Returned Product Analysis (RPA) figures, which are based on leads that have actually been removed because they were known to fail. We would expect leads that fail with warning to be removed in disproportionately high numbers because they gave a warning, while those that fail without warning might be left in place, believed to be functioning, but are actually failed.
Further, this suspicion is confirmed by the fact that Medtronic's RPA gives failure rates of only 0.8 %, vs. the failure rate of 2.3 % reported by other "vigilance" methods. Combining these two statistics means that the leads may actually fail without warning nearly 70% of the time. Medtronic is clearly hoping to contain panic on the product, because around 268,000 of them have been sold, and, after the recall of its ICD product in 2004, the company perceives its stocks and its reputation to be on shaky ground.
But there is no reason why your life should be a pawn in Medtronic's gambit to shore up investor confidence.
If you or a loved one has been implanted with Medtronic Fidelis leads, whether you have had them removed or if you are still counting on them to deliver a life-saving shock, and would like a free evaluation of your potential claim, please call or email us today.
For more information, also consult our
Sprint Fidelis ICD Lead Recall Questions Page.
