BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2100018 · Received May 23, 2011

    Report

    Report Number
    3006630150-2011-00741
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING, ELECTRICAL AND PERFORMANCE TESTS DONE. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT WHILE PROGRAMMED TO THE PATIENT'S LATEST SETTING. NO DISCREPANCIES WERE IDENTIFIED. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS WHEN CHARGED WITH RECOMMENDED OPTIMAL ALIGNMENT. WHEN ALIGNMENT OPTIMIZATION IS REDUCED, CHARGING CAN LENGTHEN CONSIDERABLY. THE BATTERY IS DEPLETING WITHIN THE TYPICAL IPG BATTERY DEPLETION RATE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS RECEIVING UNCOMFORTABLE STIMULATION. THE PATIENT WASN'T REPROGRAMMED AS THEIR IPG IS NOT CHARGING DUE TO DIFFICULTY ALIGNING THE CHARGER WITH THE IMPLANT. THE PATIENT IS SCHEDULED TO UNDERGO A AN IPG REVISION DUE TO THE IPG BEING TILTED INSIDE OF THE POCKET. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS RECEIVING UNCOMFORTABLE STIMULATION. THE PATIENT WASN'T REPROGRAMMED AS THEIR IPG IS NOT CHARGING DUE TO DIFFICULTY ALIGNING THE CHARGER WITH THE IMPLANT. THE PATIENT IS SCHEDULED TO UNDERGO A AN IPG REVISION DUE TO THE IPG BEING TILTED INSIDE OF THE POCKET. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    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 Required Intervention