BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2630397 · Received June 27, 2012

    Report

    Report Number
    3004209178-2012-04874
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Report Date
    May 30, 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
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V244043, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A LOSS OF BLADDER CONTROL. THE PATIENT STATED SHE NO LONGER FELT STIMULATION SENSATION THAT STARTED THE DAY BEFORE. THIS HAD HAPPENED BEFORE AND THE PATIENT SAID SHE'D JUST SWITCH TO A DIFFERENT PROGRAM AND EVERYTHING WOULD BE FINE. THE PATIENT COULD NOT MAKE THE ADJUSTMENT WITH THE PROGRAMMER WITH OR WITHOUT THE ANTENNA ATTACHED. THE PROGRAMMER'S BATTERIES WERE REPLACED BUT COULD NOT SYNC INS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT "THINKS SHE FELL" AT THE ONSET OF THE EVENT. IMPEDANCE READINGS WERE UNABLE TO BE OBTAINED. IT WAS UNKNOWN IF THE BATTERY WAS DEPLETED. PATIENT WAS GOING TO SELF-CATHETERIZE. PATIENT EXPERIENCED URINARY RETENTION. THERE WAS NO HOSPITALIZATION AND NO INJURY REPORTED. PATIENT WAS PLANNING TO HAVE THE BATTERY RE-IMPLANTED IN THE FUTURE.

    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