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INTERSTIM Adverse Event — Injury (MDR 3004209178-2008-00749)

INTERSTIM Adverse Event — Injury (MDR 3004209178-2008-00749) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INTERSTIM; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.; Report number: 3004209178-2008-00749.

DeviceINTERSTIM
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Report number3004209178-2008-00749
Event typeInjury
Product problemN
Date received2008-02-15
Report sourceCompany representation
NarrativeTHE MFR'S REP REPORTED, THAT THE PT HAD AN INFECTION OF HER INTERSTIM DEVICE AND THAT THE DEVICE WOULD BE EXPLANTED. THE DEVICE WAS RETURNED TO THE MFR WITH PAPERWORK CONFIRMING THE INFECTION. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
SourceopenFDA MAUDE (device adverse events)

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