BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3821704 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09297
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT# VA0HBHU, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE SETSCREW WAS BACKED OUT TOO FAR. THE SETSCREW WAS ABLE TO BE REALIGNED AND TIGHTENED DOWN ONTO A LEAD. THE RETURNED INS WAS TESTED WITH A KNOWN GOOD LEAD. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE HIGH IMPEDANCES AND THE ¿???¿ ERROR WAS NOTED. IT WAS STATED THERE WAS NO CONSISTENCY WITH REGARDS TO THE IMPEDANCE VALUES. IMPEDANCES WERE CHECKED MORE THAN 10 TIMES WITH DIFFERENT ERRORS EACH TIME. IT WAS STATED THE PHYSICIAN MADE THEIR FIRST ATTEMPT TO RATCHET THE SET SCREW IN PLACE AND BEFORE THEY TURNED THE TORQUE WRENCH A QUARTER TURN, THE WRENCH CLICKED. THIS WAS INDICATED TO BE ¿ODD.¿ PRIOR TO PLACING THE INS INTO THE PATIENT, THE LEAD SLIPPED OUT WHEN APPLYING GENTLE PRESSURE. THE LEAD WAS CLEANED AND USING THE WRENCH, THE SET SCREW IN THE INS WAS BACKED OUT A HALF TURN. THE LEAD WAS REINSERTED INTO THE INS, HOWEVER THE LEAD DID NOT SLIP OUT AFTER GENTLE TRACTION WAS APPLIED. THE PHYSICIAN THEN DID THE IMPEDANCE CHECK WHICH RESULTED IN MULTIPLE ERRORS. IT WAS NOTED THAT ALL POSSIBLE INTERFERENCES WERE TURNED OFF. IT WAS TESTED WITH A SECONDARY CLINICIAN PROGRAMMER. THE LEAD WAS ALSO REMOVED AND RETESTED WITH A PATIENT CABLE AND MOTOR RESPONSES WERE RECONFIRMED WITH IT. THE INS WAS USED WITH CYCLING ON FOR 3 SECONDS AND THEN OFF FOR 3 SECOND, BUT MOTOR RESPONSE WAS NOT ACHIEVED. THE PULSE WIDTH AND AMPLITUDE WAS ALSO INCREASED IN HOPES OF CLEARING UP THE ERRORS OF ¿>4000 OHMS¿ AND ¿???.¿ AFTER SEVERAL ATTEMPTS, A NEW INS WAS OPENED AND USED. THE ISSUES WERE NOT EXPERIENCED WITH THE SECOND INS. IMPEDANCES TESTS SHOWED NO ERRORS AND THE DEVICE WAS ABLE TO BE PROGRAMMED SUFFICIENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298927 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR