BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2463140 · Received February 21, 2012

    Report

    Report Number
    3004209178-2012-01125
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889-28, LOT# V896800, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012; LEAD: MODEL 3889-28, LOT# V896800, IMPLANTED: (B)(6) 2012, EXPLANTED UNK.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR MODEL 3085, SERIAL# (B)(4), FOUND THE SET SCREW WAS CROSS-THREADED. THE SETSCREW WAS BACKED OUT TOO FAR INTO THE TECOTHANE AND WAS MISALIGNED. THE SETSCREW WAS ABLE TO BE REALIGNED AND TIGHTENED ONTO THE LEAD. ANALYSIS OF THE LEAD MODEL 3889-28, LOT# V896800 FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS IMPLANTED AND THERE WAS NO MOTOR OR SENSORY RESPONSE WITH ELECTRODES 0-3. THE LEAD WAS INSERTED INTO THE NEUROSTIMULATOR AND HIGH IMPEDANCE MEASUREMENTS GREATER THAN 4000 OHMS WERE OBSERVED ON ALL COMBINATIONS WITH ELECTRODES 0-3. THE LEAD WAS REPLACED, BUT WITH THE SECOND LEAD IMPEDANCES CONTINUED TO SHOW GREATER THAN 4000 OHMS. IT WAS CONFIRMED THAT BLUE WAS VISIBLE IN ALL WINDOWS OF THE NEUROSTIMULATOR. THE PULSE WIDTH WAS INCREASED TO 450 AND THE AMPLITUDE TO 3.0V. IMPEDANCES WERE THEN AS FOLLOWS: C-0, 0-1, 0-2, 0-3 WERE >4000 OHMS, C-1, C-2, C-3 SHOWED "???", AND 1-2, 1-3, 2-3 WERE OK. THE LEAD WAS REMOVED FROM THE NEUROSTIMULATOR AND REINSERTED. AFTER REINSERTING THE LEAD, ALL ELECTRODES HAD GREAT RESPONSE, BUT THE LEAD WOULD NOT FIT INTO THE HEADER OF THE NEUROSTIMULATOR AND THE SET SCREW WAS NOT ABLE TO BE TIGHTENED. A SECOND NEUROSTIMULATOR WAS OPENED AND CONNECTED TO THE LEAD. WITH THE SECOND NEUROSTIMULATOR, ALL BIPOLAR READINGS WERE WITHIN NORMAL LIMITS. THERE WAS A LOT OF FLUID IN THE POCKET AND SOME IMPEDANCE MEASUREMENTS WERE SHOWING "???". ADDITIONAL INFORMATION RECEIVED REPORTED NO LEAD FRACTURES WERE NOTED. NO FURTHER INTERVENTIONS WERE NEEDED AND EVERYTHING WAS WORKING FINE. THE PATIENT RECOVERED WITHOUT SEQUELA AND WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR