BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1111748 · Received August 12, 2008

    Report

    Report Number
    2029203-2008-00564
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    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

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING LEAD PROTRUDING THROUGH SKIN. A LEAD REVISION SURGERY WAS RECOMMENDED. ALSO REFER ASSOCIATED MDR 2029203-2008-00517.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention