BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1222032 · Received November 6, 2008

    Report

    Report Number
    2029203-2008-00884
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    May 3, 2006
    Report Date
    October 9, 2008
    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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO CELLULITIS. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention LINEAR LEAD (PHASE IIIA) 50CM