Medtronic Defibrillator

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Medtronic, Inc. Pulls Heart Device Wires

After the deaths of 5 heart patients, Medtronic, Inc. pulled its Sprint Fidelis defibrillator wires from the market over concerns that the wire lead is prone to fracturing.

According to Medtronic, the electrical wires which connect the hearts of patients to the defibrillators implanted in their chests are prone to fracturing within patients’ blood vessels and dispatching a massive electrical jolt. This jolt which can be extremely uncomfortable may also be attributed to one or more of the reported deaths.

Medtronic said it had discovered a small chance of fractures in particular locations on Sprint Fidelis models 6930, 6931, 6948 and 6949. The company is asking doctors to stop implanting the leads and return all unused leads to Medtronic. The Sprint Fidelis wire is currently implanted in the hearts of 235,000 patients world-wide.

A fractured lead “can cause the defibrillator to deliver unnecessary shocks or not operate at all,” said Daniel Schultz, director of the Food and Drug Administration’s Center for Devices and Radiological Health.

When a Medtronic Sprint Fidelis lead fractures, three things can happen:

  • It may beep, alerting the patient to consult his physician immediately.
  • It may cause a massive shock to the patient, which may feel like getting kicked in the chest by a horse.
  • It may cause the defibrillator battery to deplete, which could cause the device to fail to deliver a necessary life-saving shock.