BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3953113 · Received July 23, 2014

    Report

    Report Number
    1644487-2014-01855
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    July 15, 2008
    Report Date
    June 25, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. IT WAS REPORTED THAT THE PATIENT SUFFERED RESPIRATORY FAILURE DUE TO STATUS. THE PATIENT WAS LAST SEEN BY THE PHYSICIAN IN 2008 AND NO FURTHER INFORMATION WAS KNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE STATE VITAL RECORDS WILL NOT RELEASE A COPY OF THE DEATH CERTIFICATE TO DEVICE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431311 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 016111

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death