BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR LEAD

    MDR report key: 1220395 · Received November 4, 2008

    Report

    Report Number
    2029203-2008-00863
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED STATING THAT THE PT'S LEADS HAD MIGRATED AND WERE WRAPPED AROUND THE BATTERY. THE PT WAS PROGRAMMED TO RECEIVE 50% COVERAGE. A LEAD REVISION MAY BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR LEAD LINEAR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LINEAR LEAD (PHASE IIIA): 70CM| LINEAR LEAD (PHASE IIIA): 70CM