BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1709279 · Received June 2, 2010

    Report

    Report Number
    1644487-2010-01315
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    April 30, 2010
    Report Date
    May 3, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD DIED, AND THERE WAS NO FURTHER DETAILS AVAILABLE ON THE CIRCUMSTANCES OF DEATH OTHER THAN SHE PASSED AWAY IN THE MIDDLE OF THE NIGHT WITH NO CONCERNS OF THE NIGHT BEFORE. THE DEATH WAS NOT WITNESSED. THE PT HAS HAD AN AUTOPSY PERFORMED, BUT THE REPORT HAS YET TO BE FINALIZED AND IS NOT EXPECTED TO BE AVAILABLE FOR APPROXIMATELY 3 MONTHS DUE TO PROCESSING. AS A RESULT, THE DEATH CERTIFICATE HAS YET TO BE AVAILABLE. THERE HAS NOT BEEN A DEFINITIVE CAUSE OF DEATH RULED AT THIS TIME. THE DEVICE IS EXPECTED TO BE RETURNED TO THE MFR FOR ANALYSIS FROM THE CORONER'S OFFICE. THE PHYSICIAN'S OFFICE DID NOT BELIEVE THAT THE PT'S DEATH WAS RELATED TO VNS. LAST KNOWN DIAGNOSTICS PERFORMED WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 200704

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death