BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6098299 · Received November 13, 2016

    Report

    Report Number
    1644487-2016-02631
    Event Type
    Death
    Date Received
    November 13, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 13, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS DECEASED. THE CAUSE OF DEATH IS UNKNOWN TO-DATE. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE TREATING PHYSICIAN PROVIDED THE CAUSE OF DEATH AS RESPIRATORY DISTRESS/ACUTE RESPIRATORY FAILURE, AND WAS UNRELATED TO VNS. THE DEATH CERTIFICATE WAS RECEIVED FROM THE STATE AND PROVIDED THE CAUSE OF DEATH WAS SEPSIS, DUE TO ACUTE RESPIRATORY FAILURE AS A CONSEQUENCE OF STATUS EPILEPTICUS. THE APPROXIMATE INTERVAL BETWEEN THE ONSET OF THE CAUSES AND DEATH WAS DAYS. NO AUTOPSY WAS PERFORMED AND THE MANNER OF DEATH WAS LISTED AS NATURAL. THE PATIENT WAS CREMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749368 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 203808

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death