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Medtronic - Sprint Fidelis Defibrillator

An implanted defibrillator is a medical device that is implanted in the body to help prevent sudden heart failure. It works by sending and electric shock to the heart through lead wires. Medtronic has recalled its Sprint Fidelis leads because they can fracture. A fractured lead can kill a patient by failing to deliver a needed shock or if it sends and unnecessary shock to the heart.

Medtronic Sprint Fidelis Defibrillator Lead Deaths

Defective Sprint Fidelis leads may have caused 25 deaths so far. When Medtronic pulled the leads from the market in 2007, five deaths had been reported. The death toll has continued to rise even though the device is no longer implanted.

About 150,000 Americans already have the defective leads in their bodies. Removing them can be as risky as trying to live with them. Four of the reported deaths occurred when doctors tried to remove the faulty leads.

Four models were recalled, Sprint Fidelis:

  • 6930
  • 6931
  • 6948
  • 6949

Defibrillators and the Defective Leads

Implanted defibrillators are used in patients who have certain types of problems with their heart rhythm. Some types of cardiac arrhythmia (irregular heartbeat) are fairly harmless, but certain kinds can be fatal, and can even cause sudden death. The defibrillator monitors the heart rhythm. When it detects an irregularity it can correct the problem by sending a shock to the heart.

The leads are the wires connecting the defibrillator to the heart and delivering the life-saving shock. The defective leads can fracture, crack, or break. When a wire cracks or breaks in any electronic device it can either cause the device to stop working, or it can cause a short. When defibrillator leads crack or break they can cause several things to happen:

  • A massive, painful shock delivered when the lead breaks
  • The defibrillator fails to deliver needed shocks
  • The defibrillator receives false signals and sends unnecessary shocks to the heart

All of these malfunctions can result in death.

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