BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1061963 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03262
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 19, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention EXTENSION MODEL 7489| LEADS (X2) MODEL# 3986A| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7489| EXPLANTED:| EXPLANTED: