BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6195502 · Received December 21, 2016

    Report

    Report Number
    1644487-2016-02932
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    July 1, 2016
    Report Date
    December 21, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT AFTER REACHING OUT TO A VNS PATIENT'S FAMILY REGARDING A BATTERY REPLACEMENT, IT WAS DISCOVERED THAT THE PATIENT WAS DECEASED. THE CAUSE OF DEATH WAS PROVIDED AS "COMPLICATIONS OF DISEASE PROCESS." AN ONLINE OBITUARY PROVIDED THE PATIENT DIED ON (B)(6) 2016. FOLLOW-UP TO THE FUNERAL HOME WHERE SERVICES WERE PERFORMED PROVIDED THE PATIENT¿S CAUSE OF DEATH WAS DUE TO SEIZURE DISORDER WITH ADDITIONAL HISTORY PROVIDED AS DIABETES MELLITUS AND HYPERTENSION. THE DEVICE WAS NOT EXPLANTED PRIOR TO BURIAL OF THE PATIENT. THE STATE WILL NOT PROVIDE THE DEATH CERTIFICATE TO THE MANUFACTURER. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843994 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS - HOUSTON 102 201033

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death