BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3190430 · Received June 26, 2013

    Report

    Report Number
    1644487-2013-01926
    Event Type
    Death
    Date Received
    June 26, 2013
    Date of Event
    February 26, 2012
    Report Date
    May 30, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN AND NO OTHER INFORMATION WAS KNOWN OR PROVIDED. THE GENERATOR AND LEAD WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE FUNERAL HOME DID NOT KNOW IF THE PRODUCTS WERE EXPLANTED AND IF EXPLANTED DID NOT KNOW WHAT HAPPEN TO THEM. BASED ON THE AVAILABLE INFORMATION, AN INTERNAL CLASSIFICATION SYSTEM DETERMINED THAT THE DEATH MAY BE POSSIBLE SUDEP. THE ONLY KNOWN FACTORS ARE THAT THE PATIENT HAD EPILEPSY AND DIED. AS SUCH, SUDEP CANNOT BE RULED OUT AS A CAUSE OF DEATH. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE FUNERAL HOME WAS UNABLE TO LOCATE THE DEVICES FROM THE PATIENT. THE PATIENT DIED IN HIS RESIDENCE WITH NO WITNESS TO HIS DEATH. AN AUTOPSY WAS NOT PERFORMED. THE DEATH CERTIFICATE INDICATES THAT THE IMMEDIATE CAUSE OF DEATH WAS ¿PULMONARY ARREST¿ WITH AN UNDERLYING CAUSE RESULTING IN THE PULMONARY ARREST AS BEING ¿CEREBRAL VASCULAR ACCIDENT¿ (I.E., A STROKE). THE MANNER OF DEATH WAS RULED AS ¿NATURAL¿ WITH NO AUTOPSY PERFORMED AND THE DEATH OCCURRED IN THE DESCENDANT¿S RESIDENCE WITH NO WITNESS. IT IS UNCERTAIN IF THE VNS WAS EXPLANTED PRIOR TO THE PATIENT¿S REMAINS BEING CREMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289844 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012081

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death