BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4164212 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02642
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    September 10, 2012
    Report Date
    September 16, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    AN ATTEMPT FOR THE EXPLANTED PRODUCT WAS MADE AND IT WAS REPORTED THAT THE FUNERAL HOME EXPLANT MEDICAL DEVICES RARELY BUT THAT THEY DO NOT HAVE ANY DEVICES FROM THE PAST. THE PATIENT¿S DEVICE WAS REPORTED TO HAVE BEEN DISCARDED IF IT WAS EXPLANTED. DEATH CERTIFICATE INDICATES THAT THE PATIENT'S CAUSE OF DEATH IS DUE CARDIOPULMONARY FAILURE, DUE TO HERPES SIMPLEX VIRUS ENCEPHALITIS, LENOX GASTULT SYNDROME AND HEMORRHAGIC STROKE. THE PATIENT WAS BURIED. THE MANNER OF DEATH IS NATURAL AND AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE NEUROLOGIST¿S OFFICE THAT THE PATIENT HAD A COMBINATION OF UNCONTROLLED STATUS EPILEPTICUS AND ENCEPHALITIS OF THE CNS WHEN PATIENT DIED AND THAT THE PATIENT'S CAUSE OF DEATH IS UNRELATED TO VNS. AN INTERNAL SUDEP EVALUATION WAS PERFORMED BY THE MANUFACTURER WHICH DETERMINED THE DEATH TO BE UNLIKELY SUDEP."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2012. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. NO FURTHER INFORMATION RELEVANT TO THE PATIENT¿S DEATH HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639695 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 013118

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death