BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3031675 · Received April 2, 2013

    Report

    Report Number
    3006630150-2013-00592
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. 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 ITS CHARGE WITHIN THE TYPICAL IPG BATTERY DEPLETION RATE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HIS SYSTEM AND UNDERWENT A REPLACEMENT PROCEDURE. THE PATIENT DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HIS SYSTEM AND UNDERWENT A REPLACEMENT PROCEDURE. THE PATIENT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134998 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR