BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2120255 · Received June 10, 2011

    Report

    Report Number
    3006630150-2011-00887
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS DONE. THE COMPLAINT OF THE PREMATURE BATTERY DEPLETION OF THE IPG HAS BEEN CONFIRMED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF MEASURED EXCEEDS THE TYPICAL BATTERY DEPLETION RATE. THE MICROCONTROLLER (U6), CHARGING IC (U2), CAPACITOR C22, COUPLING CAPACITORS THAT ARE ACROSS VBAT AND VDD WERE ISOLATED AND REMOVED FROM THE CIRCUIT, BUT THE SLEEP CURRENT REMAINED HIGH. THE ROOT CAUSE OF THE PREMATURE BATTERY DEPLETION IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IS NOT HOLDING A CHARGE. THE PATIENT'S DATABASE WAS ANALYZED AND PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND IS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG IS NOT HOLDING A CHARGE. THE PATIENT'S DATABASE WAS ANALYZED AND PREMATURE BATTERY DEPLETION WAS CONFIRMED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND IS DOING WELL.

    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 41 YR Required Intervention