BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1123850 · Received August 15, 2008

    Report

    Report Number
    2029203-2008-00524
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 2, 2007
    Report Date
    July 2, 2007
    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 REGARDING CHARGING ISSUES BETWEEN THE IMPLANT AND EXTERNAL EQUIPMENT. THE PATIENT'S PRECISION IMPLANT WAS REPLACED.

    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 32 YR