BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1012459 · Received March 12, 2008

    Report

    Report Number
    2029203-2008-00113
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PERMANENT IMPLANT PROCEDURE, HIGH IMPEDANCES WERE OBSERVED. TROUBLESHOOTING WAS PERFORMED BY A BOSTON SCIENTIFIC REP. THIS ISSUE COULD NOT BE RESOLVED. THE SURGEON DECIDED TO ABORT THE PROCEDURE.

    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 SC-1110| EXPLANTED: