BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1151326 · Received September 4, 2008

    Report

    Report Number
    3004209178-2008-05456
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    April 17, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT BILATERAL EXTENSION REPLACEMENT IN 2008. NO PATIENT SYMPTOMS WERE REPORTED. THE REASON FOR REPLACEMENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    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 77 YR Required Intervention EXPLANTED| EXPLANTED| EXTENISON MODEL 7489 LOT# NHU104087V| PROGRAMMER MODEL 7435 LOT# NFT054182P| EXPLANTED| LEAD MODEL 3998 LOT# V003826| EXTENSION MODEL 7489 LOT# NHU107183V