BEUDAMED
    FDA Adverse Event Death Summary report: N

    VNS THERAPY PULSE

    MDR report key: 642162 · Received October 21, 2005

    Report

    Report Number
    1644487-2005-00699
    Event Type
    Death
    Date Received
    October 21, 2005
    Date of Event
    September 22, 2005
    Report Date
    September 22, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY. IT WAS REPORTED THAT TREATING PHYSICIANS WERE UNABLE TO EXTUBATE FOLLOWING GENERATOR REPLACEMENT SURGERY AND THAT THE PATIENT WAS FOUND TO HAVE COMPRESSION OF THE TRACHEA BY THE CERVICAL SPINE, PRESUMABLY A LONG-STANDING CONDITION. THE VNS THERAPY SYSTEM WAS NOT EXPLANTED. THE PATIENT REPORTEDLY EXPERIENCED A >50% REDUCTION IN SEIZURES WITH THE VNS THERAPY AND WAS RECEIVING THERAPY AT THE TIME OF DEATH. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    DEATH CERTIFICATE LISTED IMMEDIATE CAUSE OF DEATH AS RESPIRATORY FAILURE CAUSED BY ANATOMIC THORACTIC INSUFFICIENCY, DUE TO (OR AS LIKELY CONSEQUENCE OF) INTRACTABLE EPILEPSY, DUE TO (OR AS A LIKELY CONSEQUENCE OF) CEREBRAL PALSY WITH MENTAL RETARDATION, DUE TO (OR AS A LIKELY CONSEQUENCE OF) HISTORY OF PERTUSSIS RESECTION. THE MANNER OF DEATH WAS LISTED AS NATURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. NI 13382

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death