BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2617205 · Received June 15, 2012

    Report

    Report Number
    3004209178-2012-04522
    Event Type
    Malfunction
    Date Received
    June 15, 2012
    Report Date
    May 16, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V800432, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD THAT DID NOT WORK. ELECTRODE #3 DID NOT WORK SO THE PATIENT WAS PROGRAMMED USING ELECTRODE #2. WITH THIS PROGRAMMING, THE PATIENT RECEIVED A THERAPEUTIC EFFECT THAT "WORKED FOR HER." THE PATIENT ALSO NOTED THAT SHE GAINED WEIGHT AND THEN LOST IT. THE PATIENT NOTICED THAT WHEN SHE TAKES A BATH HER NEUROSTIMULATOR MOVES AROUND IN THE POCKET. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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