BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4003163 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-15172
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 21, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-28, LOT# V325860, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION, AS WELL AS HAD NO STIMULATION SENSATION. THE PATIENT DID NOT FEEL THE ¿NORMAL FEELING¿ (STIMULATION) THAT SHE HAD WHEN THE DEVICE WAS WORKING. THE PROGRAMMER DISPLAY SHOWED ¿CALL YOUR DOCTOR¿ ICON AND A POWER ON RESET (POR) CONDITION. THE PATIENT HAD TWO PROGRAMMERS AND USED BOTH TO CHECK HER DEVICE THE MORNING OF THE DATE OF THE REPORT. BOTH OF THE PROGRAMMERS SHOWED WARNING SCREEN WITH POR MESSAGE, WHICH WAS THE FIRST TIME THE PATIENT HAD SEEN THE POR SCREEN. THE PATIENT DID NOT FEEL ANYTHING SINCE A REVISION SURGERY (B)(6) 2014 BUT DIDN¿T PAY MUCH ATTENTION IF IT WAS IMMEDIATE AFTER THE REVISION THAT DAY, AND THEN THE PATIENT STARTED NOTICING SHE WAS NOT FEELING ANYTHING AND THOUGHT MAYBE HER BODY HAD ADJUSTED TO THE STIMULATION SENSATION SO PATIENT WAS GOING TO INCREASE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478356 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR