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Implantable Pulse Generator Manufacturer Fails to Submit MDRs
Devices Inspections and Audits
Failure to submit medical device reports, inadequate risk analysis and CAPA procedures that failed to detect recurring quality issues were just a few of the nonconformances cited on a Form 483 handed to implantable devicemaker Nevro following an October 2017 inspection of the firm’s Redwood City, California plant.
The investigator noted that many complaints documented Nevro’s implantable products being removed due to infection complaints, and many of these were not reported.
The inspector reviewed 123 complaints related to reports of infections and/or deaths for which the company had not yet opened corrective or preventive action files.