BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INTERSTIM DEVICE

    MDR report key: 2192620 · Received August 2, 2011

    Report

    Report Number
    MW5021599
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    September 14, 2004
    Report Date
    July 24, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LEADS MIGRATED IN BODY. DEVICE WAS FINALLY REMOVED AFTER "READJUSTING" BY MEDTRONIC. NERVE PAIN WAS SEVERE, WOUNDS AT BASE OF SPINE HAD TO BE PACKED FOR MONTHS. I WAS ASSURED THAT THIS WAS VERY RARE AND BY IMPLANTING AGAIN WOULD MOST LIKELY WORK (SEE OTHER DEVICE FAILURE REPORT). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INTERSTIM DEVICE INTERSTIM DEVICE EZW MEDTRONIC, INC. 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R| S