Medtronic Sprint Fidelis Defibrillator Lead Recall
On October 15, 2007, Medtronic voluntarily recalled its Sprint Fidelis defibrillator leads. The following four Medtronic lead models were included in the Medtronic recall:
- Sprint Fidelis 6930
- Sprint Fidelis 6931
- Sprint Fidelis 6948
- Sprint Fidelis 6949
The recalled leads, which are thin wires that allow defibrillators to send a shock to the heart to treat abnormal heart rhythms, contain a defect that sometimes causes them to break or fracture. When the recalled Sprint Fidelis leads break, two unfavorable results can happen:
- 1. a shock may be administered when it shouldn’t be, or
- 2. there may be no shock administered when a shock would be appropriate or needed
Medtronic has admitted that the recalled Sprint Fidelis leads, which were first released on the market in 2004, may be to blame for at least five patient deaths. Unfortunately, around 268,000 people had already been implanted with Medtronic Sprint Fidelis leads by the time the recall was issued. Approximately 172,000 Sprint Fidelis leads have been implanted in the United States.
FDA Medtronic Recall Recommendations
According to the FDA, patients who have had the recalled Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. On the other hand, the FDA says that patients should not routinely seek removal of the recalled device, because the risk of removal in most patients exceeds the small risk of Sprint Fidelis lead fractures.
Patients with recalled Sprint Fidelis leads have two alternatives to removing the recalled lead. First, patients can continue using the recalled Sprint Fidelis leads while monitoring closely for signs of fracture. Second, patients can surgically add a replacement lead. Adding a replacement lead does not require removing the recalled Sprint Fidelis lead. However, if a Sprint Fidelis lead is left in a patient without being used, the tip must be covered with a small plastic insulation.
Medtronic Lead Recall Lawyer
If you or a loved one received one of the recalled Medtronic Sprint Fidelis leads, contact our Medtronic recall lawyers today to learn about your legal rights and options.