BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1400520 · Received June 11, 2009

    Report

    Report Number
    2029203-2009-01176
    Event Type
    Injury
    Date Received
    June 11, 2009
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN PATIENT. ADDITIONAL SUSPECT DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8116-70 DESCRIPTION: ARTISAN 2X8 PADDLE LEAD THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO SEROMA. THE PHYSICIAN REMOVED THE SEROMA AND THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention