BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY

    MDR report key: 527177 · Received May 25, 2004

    Report

    Report Number
    6000032-2004-00670
    Event Type
    Other
    Date Received
    May 25, 2004
    Date of Event
    April 2, 2004
    Report Date
    April 2, 2004
    Manufacturer
    MEL REL, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER REPRESENTATIVE REPORTED DEVICES WERE REMOVED DUE TO INFECTION. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY IPG LGW MEL REL, INC. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other EXPLANT: 2004.| LEAD MODEL 3890 LOT# J0235607V, IMPLANTL 2003,| EXPLANT: 2004,| EXPLANT: 2004,| EXT MODEL 7489 LOT# NHU006353V, IMPLANT: 2003,| EXT MODEL 7489 LOT# NHU003732V, IMPLANT: 2003,| LEAD MODEL 3890, LOT #J0235607V, IMP: 2003,| EXPLANT: 2004,