Medtronic Warned About Problems at Heart Device Plant

The Food and Drug Administration has warned Medtronic Inc. about problems found during a recent inspection of the company’s Minnesota facility where pacemakers and other cardiac devices are made.

Problems noted in the FDA warning letter involve the company’s corrective and preventive action, a review and documentation of field action recommendations, supplier qualification and controls, and medical device reporting timeliness, according to a Reuters news report.

The world’s largest medical device maker has 15 days to respond to the FDA warning letter and explain to the agency how it plans to address the safety concerns at its Mounds View facility, officials said.

Earlier Medtronic Recalls and Warnings

Medtronic has been in hot water before for problems with its cardiac rhythm devices.

In September, the company recalled about 6,300 defibrillators after it was determined the batteries in the Medtronic Concerto CRT-D (cardiac resynchronization therapy defibrillators) and Medtronic Virtuoso ICD defibrillators may run out of juice sooner than designed. Some patients had to have surgery to replace the batteries when their defibrillators died.

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 them to malfunction.

Those recalls followed an earlier recall, in May, involving about 37,000 pacemakers due to a wiring defect that made them unresponsive or caused them to run out of battery power.

Sprint Fidelis Recall

In 2007, Medtronic recalled its Sprint Fidelis heart defibrillator leads, which are thin wires that connect defibrillators to the heart and deliver an electrical charge when needed to restore proper heart rhythm. At least 18 patients have died after the leads fractured, causing complications with the defibrillators.

Another 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 to the heart 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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