BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2549826 · Received April 26, 2012

    Report

    Report Number
    3004209178-2012-02698
    Event Type
    Injury
    Date Received
    April 26, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28 LOT# V223166 IMPLANTED: (B)(6) 2009 EXPLANTED: NA. PATIENT PROGRAMMER MODEL 3037 SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPLACEMENT (SEE MFR 6000032-2012-00039 FOR ISSUES PRIOR TO REPLACEMENT), THE PATIENT'S DEVICE MOVED FROM HER HIGHER HIP AREA TO THE LOWER BUTTOCK REGION. IT CAUSED DISCOMFORT WHEN SHE PULLED ON A PAIR OF JEANS. THE PATIENT WAS TOLD BY HER HCP THAT HER BODY FIGHTS THE DEVICE LIKE IT'S A FOREIGN OBJECT. THE PATIENT INTENDED TO HAVE THE DEVICE EXPLANTED AFTER RELOCATING TO ANOTHER STATE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention