Medtronic Warns About Faulty Batteries in Implanted Heart Devices

Medtronic Inc., a worldwide leader in heart defibrillators, pacemakers, and other implantable heart devices, is warning patients and doctors about problems with the batteries in about 6,300 of the company’s defibrillators.

The batteries in Medtronic Concerto CRT-D (cardiac resynchronization therapy defibrillators) and Medtronic Virtuoso ICD defibrillators may run out of juice sooner than designed, the company said in a warning letter sent to heart doctors last week. The devices are implanted in the chests of heart patients to help manage potentially life-threatening irregular heartbeats.

Medtronic said the devices were made mostly in 2006 and carry the same low-voltage capacitors. Patients with the devices implanted in their bodies do not need to take any action with regards to the batteries, Medtronic said.

“There is no risk of sudden loss of output and these devices will continue to deliver therapy as needed until they reach end of service. Patients do not need to seek medical treatment or do anything differently if they are carrying the devices,” Medtronic said in a statement, according to a Reuters News report.

Past Medtronic Problems

While the company said there have been no deaths or injuries reported and that the devices still give three months’ notice before their batteries die, the news of problems with Medtronic defibrillators is troubling. Medtronic has been dogged for years by reports of deadly complications suffered by patients using the company’s heart devices.

In June, the company announced a recall of about 21,000 implanted Kappa and Sigma series pacemakers because wires inside the devices that connect the electronic circuit to the battery and other components might break, causing it to malfunction. Then, in July, Medtronic recalled about three million of its insulin infusion sets because the units might deliver incorrect amounts of insulin to patients, possibly causing severe injury or death.

Sprint Fidelis Recall

Those actions followed the 2007 recall of Medtronic’s Sprint Fidelis heart defibrillator leads, thin wires that connect defibrillators to the heart. The wires deliver an electrical charge when needed to restore proper heart rhythm.

About 18 patients have died after the leads fractured, causing complications with the defibrillators. At least 100 other Sprint Fidelis patients have reported malfunctions in the devices, causing painful charges to be delivered when they were not needed or preventing the defibrillators from delivering a life-saving jolt when it was needed.

About 268,000 Sprint Fidelis leads were implanted in patients worldwide, Medtronic says. About 100,000 people still carry the potentially defective heart devices.

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