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Medtronic Defibrillators
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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.

According to Medtronic, some of the 5 reported deaths involved inappropriate shocks, but the company did not specify the cause of death. The other deaths involved battery depletion, which caused the defibrillator to fail to dispatch an electrical shock when it was necessary to save a patient's life.

Medtronic is not recommending that patients have the Sprint Fidelis wires removed. Because leads are threaded through a vein toward the heart, and tend to have scar tissue build up around them, removing a lead can be a dangerous procedure.
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Heart patients sue Medtronic over device
MINNEAPOLIS - A man who claims he received 47 unneeded jolts from his implanted defibrillator is suing Medtronic over the broken wires the company is recalling.Plaintiffs Leonard Stavish and Kelly Luisi seek class-action status in U.S. District Court in Minneapolis as representatives of people they say were hurt. The lawsuit's allegations include emotional distress and negligence, and it seeks restitution, disgorgement of profits, and punitive damages.
Medtronic Pulls Defibrillation Leads
MINNEAPOLIS - Recalls had already battered the heart device industry when Medtronic warned doctors on Monday that the wires connecting a patient's heart to its implantable defibrillators break too often. Medtronic told doctors to stop using the Sprint Fidelis wires after linking five deaths to breaks in them.