BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1111834 · Received August 13, 2008

    Report

    Report Number
    2029203-2008-00516
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED THAT THE PT'S TRIAL LEAD HAD BROKEN WHEN BECOMING SNAGGED. THE SURGEON EXPLANTED THE REMAINING PORTION OF THE BROKEN LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2208-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1