MINNEAPOLIS (AP) — Medtronic says it is responding to a warning letter it received from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division.
Medtronic says the FDA inspected the Mounds View, Minn., location in August and found problems involving the way it prevents or responds to problems in the field, documents recommendations, reports to the FDA on its devices and implements quality control for suppliers.
The unit makes cardiac rhythm disease implants, which can include pacemakers and other surgically implanted devices.
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 says it has already started making changes.
