BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1052585 · Received May 22, 2008

    Report

    Report Number
    2029203-2008-00341
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE DISCARDED BY THE MEDICAL FACILITY, AND WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    DURING A REVISION PROCEDURE, THE SURGEON OBSERVED DAMAGE TO THE PT'S LEADS. THE LEADS WERE REPLACED. THE PT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-8116-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| SC-8116-70