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Medtronic Heart Leads
An implantable cardioverter-defibrillator (ICD) is a device that monitors and helps regulate the rhythm of the heart. An integral element of this device is the "lead," a small wire that connects the defibrillator, implanted near the shoulder, to the heart itself. The lead functions by attaching to the actual muscles of the heart, allowing the defibrillator to send a shock to the heart if it has begun to beat too rapidly.
One such lead, the Medtronic Sprint Fidelis, was removed from the market in October 2007 after it was linked to major complications and patient deaths. According to the FDA, this particular lead is prone to fracture, which "can cause the defibrillator to deliver unnecessary shocks or not operate at all." The FDA reports that already, at least five deaths and numerous major complications have been linked to Sprint Fidelis fractures.
The following model numbers are those affected by this particular risk:
- Sprint Fidelis 6930
- Sprint Fidelis 6931
- Sprint Fidelis 6948
- Sprint Fidelis 6949
Due to the nature of heart conditions, it is often difficult to remove the dangerous wire without causing further risk to the patient's heart. Therefore, despite the risk of fracture and the FDA's concerns, it is estimated that at least 235,000 people still have the Medtronic Sprint Fidelis defibrillator lead implanted in their body.
Medtronic, the manufacturer of Sprint Fidelis leads, is the world's largest medical technology company. To date, More than 1,600 injuries have been reported and numerous lawsuits have been brought against Medtronic because their Sprint Fidelis leads have caused defibrillators to either misfire or fail to work at all.
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