BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3833759 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09667
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-28, LOT# VA0FCSR, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING BLADDER SPASMS AND NO STIMULATION SENSATION A DAY PRIOR TO THIS CALL. PATIENT STATED, THE FLOW WOULD JUST COME OUT. PATIENT STATED SHE HAD NOT USED THE PROGRAMMER SINCE IMPLANT. PATIENT ASKED IF THE STIMULATION COULD BE OFF SINCE SHE HAD NOT USED HER PROGRAMMER. THE PATIENT HAD A HARD TIME GETTING THE PROGRAMMER AND NEUROSTIMULATOR (INS) TO SYNC. PATIENT STATED SHE HAD ANTENNA RIGHT OVER THE DEVICE AND WAS DIRECTLY OVER HER SKIN NO CLOTHING OR BANDAGES. AFTER SEVERAL ATTEMPTS PATIENT FINALLY GOT INS TO SYNC AND THE PROGRAMMER CONFIRMED STIMULATION WAS ON AT 1.2V ON PROGRAM 2. IT WAS INDICATED THAT PATIENT LOST CONNECTION. PATIENT STATED SHE WOULD CONTINUE TO TRY AND SYNC AND INCREASE THE STIMULATION AS NEEDED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310398 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR