BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2924091 · Received January 22, 2013

    Report

    Report Number
    3006630150-2013-00111
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTLY CHARGING WAS CONFIRMED. SLEEP CURRENT WAS SLIGHTLY OUT OF THE EXPECTED RANGE. DEPLETION RATE WAS HIGHER THAN EXPECTED. IT WAS DETERMINED THIS SLIGHTLY HIGHER THAN NORMAL CURRENT DRAIN WAS FROM THE ANALOG/DIGITAL IC SECTION OF THE IPG ELECTRONICS. IT COULD NOT BE DETERMINED CONCLUSIVELY, WHICH IC IS THE ROOT CAUSE OF THE FAILURE AS BOTH COMPONENTS ARE COVERED IN EPOXY WHICH MAKES TEST POINTS INACCESSIBLE AND TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL IS NOT POSSIBLE. THE IPG PASSED ALL OTHER FUNCTIONAL TESTS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE DUE TO PREMATURE BATTERY DEPLETION

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE DUE TO PREMATURE BATTERY DEPLETION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31093 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR