BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1080200 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04249
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 23, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THE REPORT. FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS NOT RECEIVING "GOOD" STIMULATION. THE LEAD WAS REPLACED DUE TO POSSIBLE LEAD MIGRATION OR LEAD FRACTURE. THE PT RECOVERED WITHOUT SEQUELA.

    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 31 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 7435 LOT# NFT038866P| LEAD MODEL 3487A-33 LOT# J0406352V| EXPLANTED:| ADAPTOR MODEL 3550-09 LOT# LB9921| IMPLANTED,| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU046586V