BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3070796 · Received April 22, 2013

    Report

    Report Number
    3006630150-2013-00815
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT ANALYSIS INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE, PHOTOGRAPHIC AND VISUAL TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS CONFIRMED. SLEEP CURRENT WAS SLIGHTLY OUT OF THE EXPECTED RANGE. DEPLETION RATE WITH STIMULATION TURNED OFF WAS SLIGHTLY HIGHER THAN EXPECTED. IT WAS DETERMINED THIS SLIGHTLY HIGHER THAN NORMAL CURRENT DRAIN WAS FROM THE ANALOG/DIGITAL IC SECTION OF THE IPG ELECTRONICS. IT COULD NOT BE DETERMINED CONCLUSIVELY, WHICH IC IS THE ROOT CAUSE OF THE FAILURE AS BOTH COMPONENTS ARE COVERED IN EPOXY WHICH MAKES TEST POINTS INACCESSIBLE, AND TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL IS NOT POSSIBLE. THE IPG PASSED ALL OTHER FUNCTIONAL TESTS. THE ROOT CAUSE OF THE DAMAGE IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD TO FREQUENTLY CHARGE HER IPG. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD TO FREQUENTLY CHARGE HER IPG. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171206 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1