BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 526204 · Received May 19, 2004

    Report

    Report Number
    6000032-2004-00623
    Event Type
    Death
    Date Received
    May 19, 2004
    Date of Event
    April 17, 2004
    Report Date
    April 19, 2004
    Manufacturer
    MEL REL, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDICAL EXAMINER'S INVESTIGATOR REPORTED PT EXPIRED IN 2004. CAUSE OF DEATH UNKNOWN. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT IF 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 33 YR Death 1. LEAD: MODEL 3890, LOT# J0316027V, IMP:2003,| EXP:2004.| EXT: MODEL 7495LZ, LOT# NHK026299V, IMPL: 2003| 2. EXT: MODEL 7495LZ, LOT# NHK020913V, IMP:2003,| EXP:2004.| 3. EXT: MODEL 7495LZ, LOT# NHK026299V, IMP:2003,| EXP:2004.| EXPLANT: 2004.