BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3982258 · Received August 5, 2014

    Report

    Report Number
    3006630150-2014-01816
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT BELIEVE THAT THE ELECTROCUTION WAS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION, WHILE PROGRAMMED TO THE PATIENT¿S LATEST SETTING. NO DISCREPANCIES WERE IDENTIFIED. DEVICE STIMULATION AMPLITUDE AND TIMING WAS MONITORED PER CIS PROCEDURE FOR ERRORS. NO INTERMITTENT ANOMALIES WERE NOTED IN THE OUTPUT. DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION THAT IT HAD CAUSED THE PATIENT TO FALL TO THE FLOOR AND ON ONE OCCASION CAUSED HIM DISCOMFORT. THE PATIENT¿S DEVICE ALSO ELECTROCUTED HIM. THE PHYSICIAN BELIEVED THAT IT WAS NOT IN ALL THE ANATOMICAL AREAS THE PATIENT WAS DESCRIBING, AND THAT IT WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION THAT IT HAD CAUSED THE PATIENT TO FALL TO THE FLOOR AND ON ONE OCCASION CAUSED HIM DISCOMFORT. THE PATIENT¿S DEVICE ALSO ELECTROCUTED HIM. THE PHYSICIAN BELIEVED THAT IT WAS NOT IN ALL THE ANATOMICAL AREAS THE PATIENT WAS DESCRIBING, AND THAT IT WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456942 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention