BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3110216 · Received May 13, 2013

    Report

    Report Number
    3006630150-2013-00956
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN 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 WAS NOT CONFIRMED. DEVICE EXHIBITED NORMAL CHARGING AND DISCHARGING CHARACTERISTICS WHEN CHARGED WITH RECOMMENDED OPTIMAL ALIGNMENT. WHEN ALIGNMENT OPTIMIZATION WAS REDUCED, CHARGING COULD LENGTHEN CONSIDERABLY. THE BATTERY WAS DEPLETING ITS CHARGE, WITH THE STIMULATION TURNED OFF, WITHIN THE TYPICAL IPG BATTERY DEPLETION RATE. THE SPECIFIC REASON FOR THE LOW CHARGING CURRENT WAS UNKNOWN BUT THIS CONDITION COULD OCCUR IF THE IPG IS FLIPPED, TILTED, OR DEEP INSIDE THE POCKET. DEVICE EXHIBITED NORMAL CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE HIS IPG. THE PHYSICIAN SUSPECTED THE DEVICE WAS NOT WORKING ANYMORE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE HIS IPG. THE PHYSICIAN SUSPECTED THE DEVICE WAS NOT WORKING ANYMORE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210048 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR