BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY

    MDR report key: 533140 · Received June 30, 2004

    Report

    Report Number
    6000032-2004-00841
    Event Type
    Other
    Date Received
    June 30, 2004
    Date of Event
    June 2, 2004
    Report Date
    June 23, 2004
    Manufacturer
    MEL REL, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED DEVICES REMOVED DUE TO INFECTION. THE DEVICES WERE EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION 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 27 YR Other EXP:UNK.| 4. EXT: MODEL 7495LZ, LOT# NHK025508V, IMP:2003,| EXP:UNK.| 2. LEAD: MODEL 3487A, LOT# J0313928V, IMP:2003,| EXP: UNK.| 3. EXT: MODEL 7495LZ, LOT# NHK024122V, IMP:2003,| EXP:UNK.| 1. LEAD: MODEL 3487A, LOT# J0313928V, IMP:2003,