BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1062314 · Received June 18, 2008

    Report

    Report Number
    2029203-2008-00387
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A POCKET REVISION PROCEDURE, THE IMPLANT WOULD NOT COMMUNICATE WITH THE EXTERNAL EQUIPMENT. THE PATIENT WAS UNABLE TO CHARGE THE IMPLANT PRIOR TO THE PROCEDURE. THE SURGEON DECIDED TO IMPLANT THE PATIENT 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