BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4925883 · Received July 20, 2015

    Report

    Report Number
    3004209178-2015-13696
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    May 20, 2015
    Report Date
    April 18, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0PQ91, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THE DEVICE WAS NOW ZAPPING THE PATIENT'S DERRIERE.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THE DEVICE WAS MOVING AND "FLIPS FROM BEING FLAT TO ON ITS SIDE. THE PATIENT STATED THIS HAS BEEN HAPPENING GRADUALLY SINCE THE IMPLANT. THE PATIENT REPORTED THAT SHE HAD A FALL FORWARD ONTO THEIR KNEES ON (B)(6) 2015 BUT ON THE IMPLANT. THE PATIENT HAD NOT BEEN TO ANY RECENT MEDICAL TEST OR EMI ENVIRONMENTAL EXPOSURE. IT WAS REPORTED THAT THE STIMULATOR HAS BEEN "MOVING SINCE THE SURGERY". THE PATIENT STATED FOR ABOUT A WEEK NOW IT HAD REALLY BEEN MOVING THAT SHE COULD FLIP THE STIMULATOR WITH HER HANDS. IT WAS NOTED THAT THE STIMULATOR HAS BEEN LOOSE AND MOVING SINCE THE IMPLANT. NO FURTHER INFORMATION WAS REPORTED. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470004 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR