BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1221245 · Received November 5, 2008

    Report

    Report Number
    2029203-2008-00885
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    November 1, 2006
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    2029203-09/19/08-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A REPORT WAS REC'D STATING THAT THE PT NO LONGER USED THE STIMULATOR DUE TO BURNS AND INEFFECTIVE THERAPY. THE PT'S PRECISION SYS HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-5300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE PULSE GENERATOR| LINEAR LEAD (PHASE IIIA)