BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000476 · Received February 16, 2011

    Report

    Report Number
    3006630150-2011-00219
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS DONE. THE DEPLETION RATE WITH THE STIMULATION OFF 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 GLOP TOP WHICH MAKES TEST POINTS INACCESSIBLE, AND TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL IS NOT POSSIBLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT IS EXPERIENCING CHARGING DIFFICULTY. A BSN ENGINEER ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE DEPLETION. THE PT UNDERWENT AN IPG REPLACEMENT SURGERY AND IS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING CHARGING DIFFICULTY. A BSN ENGINEER ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE DEPLETION. THE PATIENT UNDERWENT AN IPG REPLACEMENT SURGERY AND IS DOING WELL.

    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 41 YR Required Intervention