BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2990375 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03348
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 12, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), EXPLANTED: (B)(6) 2012, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ABNORMAL IMPEDANCES ON ELECTRODES 0 AND 1. IT WAS STATED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT, THE INCISION WAS ITCHING AND THEY DID NOT FEEL THE STIMULATION. IT WAS NOTED THE PATIENT SAID SHE HAD BEEN "LEAKING QUITE A BIT RECENTLY AND NEEDS TO WERE DEPENDS UNDERWEAR, SYMPTOMS IMPROVED VERY LITTLE SINCE IMPLANT, THE THERAPY DID NOT SEEM TO BE WORKING FOR THE PAST COUPLE DAYS BEFORE REPORT, WAS NOT FEELING WHAT SHE WAS SUPPOSED TO FEEL, AND THAT SHE SHOWERED THE DAY AFTER SURGERY." REPORTEDLY, THE DEVICE WAS IMPLANTED ON (B)(6) 2013. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94098 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1