BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2802685 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09457
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 25, 2012
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889, LOT# V949844, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. SINCE THE PATIENT STARTED WORKING AS A CASHIER SIX DAYS PRIOR TO REPORT, SHE NOTICED A SHARP BURNING SENSATION AND ELECTRICAL IMPULSES.. WHEN MOVING AWAY FROM BEHIND THE COUNTER, THE 'SHARP BURNING SENSATION' WOULD STOP. THE LOCATION OF SYMPTOMS WAS IN THE RIGHT SIDE GROIN. THE PATIENT WAS ADVISED TO TURN THE DEVICE SETTINGS DOWN OR TURN IT OFF WHEN THE SYMPTOMS BEGAN. IT WAS REPORTED THAT THERAPY WAS 'WORKING GREAT OTHERWISE.' NO FALLS OR TRAUMAS WERE REPORTED TO HAVE OCCURRED. THE PATIENT HAD BEEN WORKING IN THE STORE FOR 25 YEARS, BUT HAD JUST RECENTLY STARTED AS CASHIER. ADDITIONAL INFORMATION HAS 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 MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR