BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4231275 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21048
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# VA005S0, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT NOTED: "I'M NOT FEELING THE PULSATION FOR OVER A MONTH NOW, AND I'VE BEEN TRYING TO USE THE PROGRAMMER BUT IT'S NOT WORKING". PATIENT INJURY WAS NOTED. THE PATIENT STATED: "I FEEL THAT MY IMPLANT HAS MOVED AND IS UP HIGHER. I HAD A FALL ON (B)(6) 2014 AND I BROKE MY ARM AND HURT MY LEG AND HIT MY HEAD AND HIP". "I DIDN'T USE THE STIMULATOR BECAUSE I WAS IN SUCH TERRIBLE PAIN AND JUST ABOUT A WEEK OR 10 DAYS AGO, I GOT THE PROGRAMMER OUT AGAIN BECAUSE I HAVE BEEN HAVING SUCH A PROBLEM WITH LEAKAGE BUT THE CONTROLLER ISN'T CONNECTING. THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT WITH ANTENNA ATTACHED. IT WAS NOTED: WON'T DO TELEMETRY WITH ANTENNA, APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. THE PATIENT WAS GETTING A POOR COMMUNICATION SCREEN WHEN USING THE PROGRAMMER WITH THE ANTENNA. THE PATIENT WAS ONLY ABLE TO MAKE A CONNECTION WITHOUT THE ANTENNA. STIMULATION WAS ON AND SHE WAS AT 5.2. THE PATIENT INCREASED STIMULATION AND STATED SHE COULD FEEL IT S LIGHTLY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715944 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR