BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1211052 · Received October 24, 2008

    Report

    Report Number
    3004209178-2008-06851
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 21, 2006
    Report Date
    September 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT WAS RELOCATING AND HAD BEEN DOING A LOT OF BENDING, TWISTING, AND LIFTING. IT WAS DETERMINED THAT THE PATIENT'S LEADS WERE KINKING AND WERE TOO FRAGILE. THE PATIENT'S STIMULATION SYSTEM WAS REMOVED AND REPLACED WITH A SYSTEM FROM A DIFFERENT MANUFACTURER. NO PATIENT OUTCOME WAS REPORTED.

    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 7489| EXPLANTED:| PROGRAMMER MODEL 7435| EXPLANTED:| LEAD MODEL 3890| LEAD MODEL 3890