BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 4646199 · Received March 31, 2015

    Report

    Report Number
    1644487-2015-04322
    Event Type
    Death
    Date Received
    March 31, 2015
    Date of Event
    October 31, 2007
    Report Date
    March 30, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, A DEATH CERTIFICATE WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2007 AND THE PATIENT¿S CAUSE OF DEATH WAS CARDIOPULMONARY ARREST DUE TO (OR AS A CONSEQUENCE OF) HYPOXIA DUE TO (OR AS A CONSEQUENCE OF) SEIZURE DISORDER (GRAND MAL). THE DEATH WAS SUDDEN, WITHIN MINUTES, AND THE DEATH CERTIFICATE INDICATES THAT NO AUTOPSY WAS PERFORMED. THE PLACE OF DEATH IS DOCUMENTED AS "OWN HOME." A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED BY THE MANUFACTURER AND IT WAS DETERMINED THAT THE DEATH WAS CLASSIFIED AS PROBABLE SUDEP, ALTHOUGH THERE IS NO INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211850 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 1988

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death