BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2030044 · Received March 25, 2011

    Report

    Report Number
    3006630150-2011-00412
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS PERFORMED. THE DEVICE WAS CONFIRMED TO BE IN HIBERNATION UPON RECEIPT. THE DEVICE WAS SUCCESSFULLY CHARGED TO FULL CAPACITY IN TWO CHARGE CYCLES, AND ALL TESTING INDICATED THE DEVICE WAS FUNCTIONING PROPERLY. THE BATTERY CHARGE PROFILE INDICATES THAT CHARGE ATTEMPTS HAD BEEN FREQUENTLY INTERRUPTED BY THE ASSOCIATED CHARGER, WHICH ARE THE CHARACTERISTICS OF A POOR AIR VENTILATION AROUND THE PATIENT'S CHARGER. BATTERY DEPLETION RATE WITH STIMULATION TURNED OFF WAS SLIGHTLY HIGHER THAN THE SET LIMIT. QUIESCENT CURRENT WAS ALSO MARGINALLY OUT OF THE EXPECTED RANGE. THE QUIESCENT CURRENT VARIATION 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 GLOP TOP THAT MAKES TEST POINTS INACCESSIBLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING THE IPG DUE TO WEIGHT LOSS. THE PATIENT HAD LOST A SIGNIFICANT AMOUNT OF WEIGHT, MAKING THE POCKET SITE TOO SHALLOW. IN ADDITION, A BSN ENGINEER ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. DURING THE PROCEDURE, THE PHYSICIAN CHOSE TO REPLACE THE IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING THE IPG DUE TO WEIGHT LOSS. THE PATIENT HAD LOST A SIGNIFICANT AMOUNT OF WEIGHT, MAKING THE POCKET SITE TOO SHALLOW. IN ADDITION, A BSN ENGINEER ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. DURING THE PROCEDURE, THE PHYSICIAN CHOSE TO REPLACE THE IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    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 77 YR Required Intervention