BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3002885 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03683
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V085160, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED SHE NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT STATED "THIS THING DOESN'T WORK." IT WAS STATED THAT THE THERAPY "TURNED OFF" AND THAT PATIENT HAD LEFT IT OFF EVER SINCE. IT WAS NOTED THAT THE PATIENT'S SON AND PATIENT'S DOCTOR HAD "SET IT OFF" AND SENT "ELECTRICAL CURRENT" THROUGH HER BODY. IT WAS STATED THAT "IT HURTS ALL THE TIME" AND THAT "IT FEELS LIKE BEING ELECTROCUTED." IT WAS NOTED THAT THE PATIENT REPORTED THE PAIN TO HER HEALTH CARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104791 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1