Medtronic Issues Alert on Sigma Pacemakers
Medtronic Inc., the world’s biggest maker of electronic heart devices, said it was notifying doctors about a potential defect in certain Sigma series pacemakers after some patients said they felt dizzy or fainted.
No deaths or injuries were reported, a spokesman for Minneapolis-based Medtronic said. About 28,000 pacemakers, including 6,650 in the U.S., are covered by the advisory.
Medtronic said the defect occurred when a solvent used to clean pacemaker wires degraded them over time, causing the wires to break from the circuitry in 19 devices.
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