Medtronic, FDA Hit With Suit Over Spinal Cord Stimulator Defects

Medtronic Inc. made a damaging spinal cord stimulator system and evaded rigorous regulatory scrutiny for decades of updates to the device, according to a patient’s lawsuit filed Friday.

The US Food and Drug Administration gave the class III device pre-market approval in 1984, and since then the company has submitted supplements that extensively changed how the devices is made and works, the complaint filed in the US District Court for the District of Minnesota said.

“By utilizing the PMA Supplement process instead of filing a new PMA application, Medtronic avoided the rigorous scientific review, public comment, and clinical trial requirements ...