BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3951292 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13394
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE ACCESSORY. (B)(4). FINAL ANALYSIS OF THE TINED LEAD SERIAL # UNKNOWN, REVEALED OPEN CIRCUIT 0, 1 AND NO SHORT BETWEEN CIRCUITS. IT WAS NOTED THAT 0 AND 1 WELDS ARE BROKEN AT THE DISTAL END. FINAL ANALYSIS OF THE NEUROSTIMULATOR SERIAL # (B)(4) REVEALED NO SIGNIFICANT ANOMALY, THE SETSCREW BACKED OUT TOO FAR.

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE CALLER WAS IN STAGE 2 INTERSTIM CASE AND THE INITIAL BATTERY DOING THE SAME THING AS THE 2ND NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT IMPEDANCE READING WAS >4000 OHMS ON SOME OF THE BIPOLAR PAIRS, WHICH WAS REPORTED AS FOLLOWS: C0 >4K C1 >4K01 >4K 02 >4K 03 >4K 12 >4K 13 >4K. IT WAS INDICATED THAT THE LEAD WAS TIGHT IN HEADER, DIDN'T PULL OUT. THE CALLER REPORTED IT WAS SEATED PROPERLY. THEY WAS SLIGHT HESITATION INTO HEADER BUT DIDN'T HAD TO FORCE IT IN. IT WAS INDICATED THAT THEY ATTEMPTED MOTOR RESPONSE AT 13 WITH 4.4V AND NO RESPONSE, ATTEMPTED MOTOR RESPONSE AT 01 AT 5V AND NO RESPONSE, AND ATTEMPTED MOTOR RESPONSE AT 23 AND BELLOWS. CALLER WOULD DISCUSS THIS OPTION OR REPLACING THE INS. IT WAS INDICATED THAT FAILED INS WAS NOTED. WE REPLACED THE TINED LEAD AND NOTICED A SMALL NICK IN THE INSULATION ABOVE THE WHITE DEPTH INDICATOR. ONCE LEAD WAS REPLACED THE INS SHOWED NO OPEN CIRCUITS. PATIENT WAS PROGRAMMED ON -1, +3 AT AMP OF 1.1, PW 210 AND RATE 14. IT WAS INDICATED THAT DURING THE PROCEDURE ON THE DAY OF THE CALL, CALLER WAS IN STAGE INTERSTIM PROCEDURE AND WAS GETTING HIGH IMPEDANCES ON ALL PAIRS EXCEPT A COUPLE. THEY INCREASED VOLTAGE AND PULSE WIDE (PW) BUT THIS DIDN'T RESOLVE THE ISSUE. THEY REINSERTED LEAD BUT THIS DIDN'T RESOLVE ISSUE THE EITHER. THEY TRIED ANOTHER INS BUT GOT SAME HIGH IMPEDANCES. THEY THEN CHANGED OUT THE LEAD AND THE IMPEDANCES RESOLVED. THEY NOTED A NICK IN THE LEAD ABOVE THE DEPTH INDICATOR. CALLER DID NOT THINK THAT COULD HAVE OCCURRED DURING THE STAGE 2 PROCEDURE BECAUSE HEALTH CARE PROVIDER WOULDN'T HAVE BEEN THAT TOO CLOSE TO THAT AREA. POST OPERATIVELY, PATIENT PROGRAMMED TO 1-3+, 1.1V, 210, 14HZ AND PATIENT GETTING GOOD STIM. IT WAS LATER REPORTED THAT THE LEAD AND THE NEUROSTIMULATOR WAS REMOVED AND REPLACED. IT WAS NOTED THAT PATIENT FELT STIMULATION AT 1.0 WITH 210 PW AND 14 RATE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429033 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR