BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1403535 · Received June 4, 2009

    Report

    Report Number
    2029203-2009-01404
    Event Type
    Other
    Date Received
    June 4, 2009
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    ON 01/26/2009, BOSTON SCIENTIFIC NEUROMODULATION CORPORATION RECEIVED INFORMATION STATING THE PATIENT WAS UNABLE TO OBTAIN SIMULATION IN THEIR PAIN AREAS. THE PATIENT ELECTED TO HAVE THE PRECISION SYSTEM REMOVED. AS NOTED IN THE DEVICE LABELING A PERCENTAGE OF PATIENTS THAT ARE PERMANENTLY IMPLANTED MAY EXPERIENCE INEFFECTIVE PAIN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1