The QMN Weekly Bulletin

Medtronic Neuro Gets Warning Letter, FDA Wants to Meet on Motor Flaws

Sept. 7, 2012

Medtronic’s neuromodulation unit has received an FDA warning letter on allegations the business segment did not handle complaints properly, among other corrective and preventive action (CAPA) violations.

The letter — dated July 17 and posted to the FDA website earlier this month — was issued by the agency’s Minneapolis District Office after an inspection of the Medtronic Neuromodulation facility in Minneapolis, Minn. A six-observation Form 483 was issued at the close of the March 14 to May 9 inspection.

Chief among the concerns was that Medtronic had not properly prevented recurrence of device flaws. One source of nonconforming product, motor corrosion that caused SynchroMed II pumps to stall, racked up 567 complaints without being closed or fully evaluated, the warning letter states. Medtronic closed another 11 complaints of motor stalls with no known cause, in which the units weren’t returned, without properly investigating them or documenting why it chose not to do so, the inspectors said.

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