BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3092761 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07301
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 18, 2013
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V394050, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS THAT STARTED ABOUT TWO WEEKS AGO AND THE PATIENT HAD NOT BEEN PLEASED WITH THERAPY. THE PATIENT HAD NOT BEEN IN TOO MANY TIMES FOR REPROGRAMMING, BUT WOULD FEEL STIMULATION AFTER CHANGES WERE MADE AND THEN GOT USED TO THEM. IT WAS NOTED THAT TWO WEEKS AGO THE PATIENT SAW DISPLAYED ON THE PATIENT PROGRAMMER A POR (POWER ON RESET) CONDITION AND AN EOS/EOL (END OF SERVICE/END OF LIFE) MESSAGE. A LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE DEVICE BATTERY LIFE BASED ON PATIENT'S SETTINGS ON PROGRAM 3, 8.5 V, 201 PW, 25 HZ, CYCLING OF 10 SEC ON/OFF, 24/7 USE, C+,2-,1-, WHICH RESULT WAS 3.83 MONTHS TO EOS. IT WAS INDICATED THAT DUE TO PATIENT'S HIGH SETTINGS, THERE WAS A LIKELIHOOD OF THE BATTERY BEING REPLACED SOON. IT WAS ALSO REPORTED THAT IMPEDANCES WERE HIGH ON SOME OF THE BIPOLAR PAIRS. AN IMPEDANCE CHECK RESULTED IN THE FOLLOWING: C0=>4000 OHMS, C1=691 OHMS, C2=>4000 OHMS, C3=3729 OHMS, 01=1746 OHMS, 02=>4000 OHMS, 03=>4000 OHMS, 12=3498 OHMS, 13=3993 OHMS, AND 23=>4000 OHMS. IT WAS INDICATED THAT THE PATIENT WAS NOT AWARE OF ANY ACCIDENTS/INCIDENTS, FALLS OR OTHER TRAUMA, BUT HE HAD BEEN WORKING IN THE YARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194821 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1