Medtronic gets FDA warning on documentation, responses, quality control in heart implant unit

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Medtronic gets FDA warning on heart implant unit

NEW YORK — Medtronic said Wednesday it is responding to a warning letter from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division.

Medtronic said the FDA inspected the Mounds View, Minn., location in August. It found problems with Medtronic’s procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues. The agency also cited problems with Medtronic’s quality control for suppliers.

Medtronic is the world’s largest medical device maker, and the cardiac rhythm disease management unit is its largest business. It makes surgically implanted devices for rapid, slow, and irregular heartbeats, and systems that monitor how those products are working.

The FDA feels Medtronic’s planned corrections are sufficient to fix the problems, Medtronic said. The Minneapolis company has 15 days to respond to the warning and said it has already started making changes.

In May, the cardiac rhythm disease unit recalled thousands of pacemakers due to a wiring defect that made them unresponsive or caused them to run out of battery power. The recall was deemed a Class I recall by the FDA, meaning the malfunction could seriously injure or kill patients.

In midday trading, Medtronic shares lost 40 cents to $39.80.