Medtronic Pacemakers Side Effects. Medtronic Inc. announced they are advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. No deaths or injuries were reported, though some users suffered dizziness or fainting, according to the Fridley-based medical-devices maker.
An estimated 28,000 pacemakers, including 6,650 in the U.S., are covered by the advisory, which Medtronic said could be classified by the U.S. Food and Drug Administration as a recall.
Medtronic said the defect took place when a solvent used to clean pacemaker wires degraded them over time, causing the wires to break from the circuitry in 19 devices. Pacemakers help spark the heart to achieve a steady, timely beat.
The company estimates that 47 to 84 units, all made between November 2001 and August 2004
The company estimates that 47 to 84 units, all made between November 2001 and August 2004, could be affected over the 10-year life of the units.
The risk to patients is extremely low, but we are alerting physicians to the issue to ensure they are aware of the situation and can appropriately care for their patients,” said Steve Mahle, president of Medtronic’s cardiac rhythm management division.
Although the company doesn’t recommend replacing the devices prior to normal elective replacement, it added that this decision should be left up to the doctor based on each patients unique circumstances.
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