BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6161640 · Received December 9, 2016

    Report

    Report Number
    1644487-2016-02834
    Event Type
    Death
    Date Received
    December 9, 2016
    Date of Event
    November 12, 2016
    Report Date
    February 6, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY THE MEDICAL EXAMINER THAT THE PATIENT HAD PASSED AWAY DUE TO SUDEP AND THAT THE FAMILY HAS RETAINED THE VNS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NEUROLOGIST THAT THE PATIENT HAD PASSED AWAY. THE PHYSICIAN DID NOT KNOW THE CAUSE OF DEATH AND DID NOT KNOW THE RELATION TO VNS; HOWEVER, SHE BELIEVED THE DEATH MAY BE SUDEP BECAUSE THEY FOUND THE PATIENT FACE DOWN. THE IN-HOUSE PROGRAMMING HISTORY DATABASE WAS REVIEWED AND THERE WERE NO ANOMALIES NOTED. THE LAST DIAGNOSTICS WERE PERFORMED ON (B)(6) 2016, WHICH SHOWED AND IMPEDANCE VALUE OF 2144 OHMS, WHICH IS WITHIN NORMAL LIMITS. THE PROGRAMMING HISTORY DATABASE SHOWED THE DEVICE WAS CHECKED LESS THAN A MONTH PRIOR TO THE PATIENT'S DEATH AND THE DEVICE WAS WORKING AS INTENDED. A BATTERY LIFE CALCULATION WAS ALSO PERFORMED AND SHOWED THE GENERATOR HAD APPROXIMATELY 10 YEARS REMAINING UNTIL NEOS = YES (NEAR END OF SERVICE). ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN CLARIFIED THAT THE PATIENT ACTUALLY PASSED AWAY ON (B)(6) 2016. ADDITIONALLY IT WAS REPORTED THE THAT VNS BATTERY WAS FULL IN (B)(6) 2016. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811800 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202575

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death