BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4111808 · Received September 23, 2014

    Report

    Report Number
    1644487-2014-02435
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    September 27, 2010
    Report Date
    August 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    PER THE NATIONAL DEATH INDEX, THE PATIENT'S CAUSE OF DEATH IS STATUS EPILEPTICUS, RESPIRATORY DISTRESS AND RESPIRATORY ARREST. DEATH CERTIFICATE WAS ALSO RECEIVED AND CONFIRMS THAT THE PATIENT'S CAUSE OF DEATH WAS RESPIRATORY ARREST (12 HR) DUE TO STATUS EPILEPTICUS DUE TO OR DUE TO ADULT RESPIRATORY DISTRESS SYNDROME. THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. THE MANNER OF DEATH WAS NATURAL AND PATIENT WAS BURIED. AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2010. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590098 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200704

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death