BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1071644 · Received July 9, 2008

    Report

    Report Number
    2029203-2008-00416
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 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 LEADS WERE DISCARDED BY THE MEDICAL FACILITY, AND WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT'S LEADS WERE EXPLANTED DUE TO SKIN EROSION AND INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SC-2138-50| EXPLANTED