BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM LEAD

    MDR report key: 1040036 · Received May 7, 2008

    Report

    Report Number
    2182207-2008-02438
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    May 26, 2005
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S TRIAL INTERSTIM DEVICE WORKED WELL FOR HER BUT IT GOT INFECTED. THE TRIAL LEAD WAS REMOVED AND THE PERMANENT DEVICE WAS PLACED CONTRALATERALLY. SINCE THE TRIAL THE PT'S RIGHT SIDE HAS BEEN PAINFUL WHERE THE LEAD WAS IMPLANTED. THE PT'S CURRENT PERMANENT IMPLANT HAS BEEN TURNED OFF THE PAST TWO YEARS DUE TO LACK OF EFFECT. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM LEAD EZW MEDTRONIC NEUROMODULATION LEAD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention "SEE H10...."