BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3160156 · Received June 10, 2013

    Report

    Report Number
    3006630150-2013-01186
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OF THE CHARGING DIFFICULTY WAS VERIFIED. THE IPG EXHIBITS PREMATURE BATTERY DEPLETION AND EXCESSIVE SLEEP CURRENT LEAKAGE. THE PATIENT¿S PROFILE INDICATED THAT BATTERY DEPLETION RATE CHANGE HAD OCCURRED UPON IMPLANTATION. TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL WAS IMPOSSIBLE SINCE BOTH ANALOG/DIGITAL INTEGRATED CIRCUITS ARE COVERED BY EPOXY RESIN. THE SOURCE OF THE DEVICE DAMAGE WAS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WOULD NOT HOLD CHARGE. DATABASE ANALYSIS REVEALED PREMATURE BATTERY DEPLETION. THE PATIENT UNDERWENT BATTERY REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WOULD NOT HOLD CHARGE. DATABASE ANALYSIS REVEALED PREMATURE BATTERY DEPLETION. THE PATIENT UNDERWENT BATTERY REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260772 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR