More Deaths Linked to Faulty Medtronic Heart Defibrillator Leads

Thirteen more patient deaths have been linked to recalled heart defibrillator leads made by Medtronic Inc., the company said in a letter to physicians.

The increased death toll comes in response to a new report issued by a panel of physicians who reviewed allegations that the company’s Sprint Fidelis leads could fail to work properly, causing patient deaths and injuries. The Medtronic Sprint Fidelis leads are metal wires which connect a heart defibrillator to a patient’s heart to deliver an electrical charge when needed to restore heart rhythms.

The Sprint Fidelis leads were recalled in 2007 after being blamed for breaking and failing to deliver a life-saving charge when needed or delivering unnecessary charges. Previously, Medtronic had said that only five people had died as the result of the faulty wire leads. Medtronic is the world’s largest maker of electronic heart devices.

Four of the 13 newly reported patient deaths occurred as physicians operated to remove the devices from patients, the company said. The report reviewed 89 of 107 reports of Sprint Fidelis leads malfunctioning in patients and found that broken wires were a “possible or likely contributing factor” in the cases.

An estimated 268,000 Sprint Fidelis leads were implanted in people worldwide, according to Medtronic. More than an estimated 100,000 people still carry the devices.

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