BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3882163 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01530
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT WAS LAST SEEN BY HER NEUROLOGIST ON (B)(6) 2013. NO ISSUES WERE NOTED DURING THE OFFICE VISIT. THE NEUROLOGIST'S OFFICE WAS UNAWARE OF THE PATIENT'S DEATH AND WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE PHYSICIAN'S OFFICE DID NOT HAVE ANY DETAILS SURROUNDING THE PATIENT'S DEATH. THE ONLINE OBITUARY IDENTIFIED THE DATE OF DEATH. THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE FUNERAL HOME REPORTED THAT NO AUTOPSY WAS PERFORMED, AND THAT THE VNS DEVICES WERE NOT REMOVED PRIOR TO BURIAL. THE DEATH CERTIFICATE SIGNED BY THE COUNTY MEDICAL EXAMINER REPORTEDLY INDICATES THE CAUSE OF DEATH WAS SUDDEN UNEXPECTED DEATH IN EPILEPSY (SUDEP). CONTRIBUTING FACTORS ARE UNSPECIFIED SEIZURE DISORDER, SLEEP APNEA, CHRONIC PAIN SYNDROME, AND BIPOLAR. THE MANNER OF DEATH WAS DETERMINED TO BE NATURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358610 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202021

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death