BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3943580 · Received July 18, 2014

    Report

    Report Number
    1644487-2014-01827
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    February 21, 2013
    Report Date
    June 24, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY DUE TO SUDEP. THE PATIENT'S LAST KNOWN TREATING PHYSICIAN REPORTED THAT HE WAS NOT SEEING THE PATIENT AT THE TIME OF DEATH AND HAS NO FURTHER INFORMATION REGARDING THE DEATH. THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422335 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 200759

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death