BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1202894 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06680
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT GETTING THERAPEUTIC EFFECT FROM HIS DEVICE AND FELT NO STIMULATION SENSATION. HE STATED THAT THE LEAD WAS "STICKING OUT" OF HIS BACK. THE DEVICE WAS EXPLANTED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| PROGRAMMER MODEL 3037 LOT# NJD038753N| LEAD MODEL 3889 LOT# V015940| EXPLANTED