BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3213809 · Received July 9, 2013

    Report

    Report Number
    3006630150-2013-01408
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S WHOLE SYSTEM WAS REPLACED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. DEVICE EVALUATION INDICATED THAT THE LEADS REVEALED FRACTURED CABLES AT THE BENT/KINKED LOCATION OF THE LEAD. THIS LOCATION APPEARED TO BE THE SITE WHERE THE CLIK ANCHOR HAD BEEN POSITIONED. THE BROKEN CABLES RESULTED IN THE REPORTED COMPLAINT OF HIGH IMPEDANCE EXHIBITED. DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE REPORTED ELECTRICAL SURGE COULD NOT BE DUPLICATED ON THE TEST BENCH. SINCE THE RETURNED LEADS EXPOSED SUBSTANTIAL DAMAGES, THE IPG WAS INVESTIGATED WITH KNOWN GOOD LEADS. THE MONITORED STIMULATION FOUND THAT THE OUTPUTS WERE CONSISTENT AND AMPLITUDE/PULSE WIDTHS WERE VERIFIED TO BE CORRECT ON ALL THE UNBROKEN ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE WAS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING A JOLTING SENSATION PERIODICALLY WHEN THE STIMULATION WAS ON. DATABASE ANALYSIS NOTED HIGH IMPEDANCES ON ACTIVELY USED ELECTRODE. THE PATIENT WILL UNDERGO AN EXPLANT-REIMPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING A JOLTING SENSATION PERIODICALLY WHEN THE STIMULATION WAS ON. DATABASE ANALYSIS NOTED HIGH IMPEDANCES ON ACTIVELY USED ELECTRODE. THE PATIENT WILL UNDERGO AN EXPLANT-REIMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312002 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR