Medtronic Warns of Potential Pacemaker Problems

Medtronic Inc., a leading maker of pacemakers and defibrillators, is warning about the potential for problems from faulty wiring in about 37,000 of its older pacemakers.

More than 1.7 million of the company’s Kappa and Sigma pacemakers have been implanted since 1997, and Medtronic said it first noticed wiring problems in some units in 2005. The faulty wiring can cause the pacemakers to fail at a higher-than-expected rate, the company said this week.

A wire separation problem inside the pacemakers and issues associated with the use of a cleaning solvent during the manufacturing of the units are suspected of causing the wiring problems, Medtronic said.

The wire separation issue involves 15,200 Kappa devices and 6,100 Sigma devices, officials said. There also is a small failure rate in 96,000 Kappa devices, but the company said that risk isn’t expected to increase much and there is no warning regarding those devices.

Medtronic Defibrillator Wires Previously Faulty

In 2007, Medtronic was forced to recall its Sprint Fidelis leads because the tiny wires that connect implanted defibrillators to the heart might fracture. Thousands of the leads were taken off the market after it was found they might fail to deliver a life-saving charge when needed or deliver painful electrical shocks when not needed to correct irregular heartbeats.

At least five deaths were attributed to the faulty Medtronic Sprint Fidelis leads.

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