BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1457323 · Received August 28, 2009

    Report

    Report Number
    2029203-2009-01813
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    July 30, 2009
    Report Date
    July 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L SUSPECT DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-8120-70. MODEL DESCRIPTION: ARTISAN 2X8 PADDLE LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT WAS EXPLANTED DUE TO PAIN FROM THE IMPLANT SURGERY AND INEFFECTIVE THERAPY. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention