BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1063035 · Received June 19, 2008

    Report

    Report Number
    2029203-2008-00377
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 21, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED CHARGING ISSUES BETWEEN THE IMPLANT AND THE EXTERNAL EQUIPMENT, AFTER SUFFERING MULTIPLE FALLS. THE SURGEON DECIDED TO IMPLANT THE PT WITH A NEW BOSTON SCIENTIFIC SPINAL CORD STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR SC-2138-70