BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2870389 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02327
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, OPERATIONAL, ELECTRICAL, PERFORMANCE, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS CONFIRMED. SLEEP CURRENT WAS OUT OF THE EXPECTED RANGE. DEPLETION RATE WITH STIMULATION TURNED OFF WAS SLIGHTLY HIGHER THAN EXPECTED. IT WAS DETERMINED THIS SLIGHTLY HIGHER THAN NORMAL CURRENT DRAIN WAS FROM THE ANALOG/DIGITAL INTEGRATED CIRCUIT SECTION OF THE IPG ELECTRONICS. IT COULD NOT BE DETERMINED CONCLUSIVELY, WHICH INTEGRATED CIRCUIT WAS THE ROOT CAUSE OF THE FAILURE AS BOTH COMPONENTS WERE COVERED IN EPOXY WHICH MADE TEST POINTS INACCESSIBLE, AND TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL WAS NOT POSSIBLE. THE IPG PASSED ALL OTHER FUNCTIONAL TESTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO CHARGING DIFFICULTIES. THE PATIENT IS REPORTEDLY WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT DUE TO CHARGING DIFFICULTIES. THE PATIENT IS REPORTEDLY WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR