BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4931730 · Received July 22, 2015

    Report

    Report Number
    3004209178-2015-13834
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 24, 2015
    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# VA0VRBB, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS OF STIMULATOR (B)(4) REVEALS NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPRESENTATIVE WAS GETTING QUESTION MARKS (???) IN RESULTS FOR IMPENDENCE. THE REPRESENTATIVE INTRAOPERATIVE WITH STAGE 2 IMPLANT AND GETTING "??" WITH ALL CASE PAIRS. BOTH INS (STIMULATOR) AND LEAD WERE BRAND NEW. CALLER HAD ONLY ONCE SEEN A NUMERICAL VALUE WITH A CASE PAIR (C/0) BUT CAN'T REMEMBER WHAT THE NUMBER WAS EXACTLY. BIPOLAR PAIRS HAD BEEN NORMAL RANGE. INS IN POCKET. HAD CALLER RUN IMPENDENCE AT 2 VOLTS, 390US, BUT ALL UNIPOLAR WERE ?? AND BIPOLAR WERE 01=1328, 02=1328, 03=1342, 12=1328, 13=1328, 23=1328. TRIED CONDUCTING IMPENDENCE AT 2VOLTS, 360US BUT THIS DIDN'T RESOLVE ISSUE. THEY HAD TURNED OFF LIGHT ALREADY AND THERE WAS NO FLUORO PRESENT OR BEING USED. THERE WAS OTHER MONITORING EQUIPMENT ON AND BEING USED SINCE PATIENT WAS UNDER GENERAL ANESTHESIA. THE BATTERY WAS REPLACED WITH A NEW INS AND THE IMPEDANCE WAS PERFECT THE VERY FIRST TIME. IT WAS LATER REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA AND THEREFORE UNAWARE OF ANY ISSUES WITH DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTS DURING IMPLANT THE IMPENDENCE TESTS GAVE ??? FOR ALL "C" CONFIGURATION. AFTER CALLING TECHNICAL SUPPORT A NEW INS WAS USED AND GAVE PERFECT IMPENDENCE READING. THERE WAS NO PATIENT DEATH AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476950 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR