BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3800543 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08746
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V271801, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD FALLING SEVERAL TIMES OVER THE LAST 2 MONTHS AND THE DEVICE WAS NOT WORKING PROPERLY. THE PATIENT ¿BELIEVES IT'S BECAUSE HE'S FALLEN SEVERAL TIMES AND HE'S BEEN IN THE HOSPITAL A FEW TIMES.¿ IT WAS INDICATED THAT PATIENT JUST HAD A ROUGH TIME SINCE THE MIDDLE OF SUMMER; HE HAD BEEN IN AND OUT OF THE HOSPITAL AND NURSING HOMES. THE PATIENT HAD NOT MADE ANY ADJUSTMENT WITH HIS PROGRAMMER SINCE THE PROBLEM STARTED. IT WAS INDICATED THAT PATIENT TALKED TO HEALTH CARE PROVIDER (HCP) ABOUT REMOVING THE DEVICE COMPLETELY BUT THE HCP DOES NOT RECOMMEND SURGERY TO REMOVE IT. THE HCP WANTED PATIENT TO GET THE DEVICE REPROGRAMMED OR ¿JUST LEAVE IT IN HIS BODY NOT WORKING." IT WAS INDICATED THAT PATIENT WAS NOT FEELING STIMULATION AND NOTED A POOR COMMUNICATION SCREEN WITH AND WITHOUT ANTENNA. I WAS NOTED THAT PATIENT WAS NOT BEING ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT ANTENNA ATTACHED. IT WAS INDICATED THAT PATIENT BASIC UNDERSTANDING OF: PATIENT PROGRAMMER USE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277993 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR