BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1222427 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07219
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED NO STIMULATION SENSATION FOR FOUR WEEKS EVEN THOUGH THE PARAMETERS WERE INCREASED. THE PATIENT WAS SEEN BY A PHYSICIAN. THE PATIENT HAD SURGERY TO FIX THE PROBLEM. THE DEVICE SYSTEM WAS REPLACED. THE PATIENT NO LONGER HAD PROBLEMS WITH THE SPINAL CORD STIMULATION SYSTEM. IT WAS ALSO REPORTED THE PATIENT'S PROGRAMMER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXTENSION MODEL 7495-51 LOT# XR0011692N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD MODEL 3587A LOT# L30083