BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3200491 · Received July 1, 2013

    Report

    Report Number
    3006630150-2013-01362
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. THE IPG WAS CHARGED IN TWO CYCLES FROM ITS HIBERNATION. THE BATTERY DEPLETION AND SLEEP CURRENT RATES WERE WITHIN NORMAL RANGES. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG NEVER CHARGED FULLY. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG NEVER CHARGED FULLY. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300018 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR