BEUDAMED
    FDA Adverse Event Death Summary report: N

    VNS THERAPY PULSE

    MDR report key: 538982 · Received August 13, 2004

    Report

    Report Number
    1644487-2004-00672
    Event Type
    Death
    Date Received
    August 13, 2004
    Date of Event
    July 14, 2004
    Report Date
    July 15, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT WENT TO THE EMERGENCY ROOM AFTER EXPERIENCING CARDIAC ARREST, AND SUBSEQUENTLY DIED. THE DEATH CERTIFICATE LISTED THE IMMEDIATE CAUSE OF DEATH AS CARDIAC ARRHYTHMIA, DUE TO (OR AS A CONSEQUENCE OF) HYPOXIA, DUE TO (OR AS A CONSEQUENCE OF) RECURRENT SEIZURES. THE MANNER OF DEATH WAS LISTED AS NATURAL. AN AUTOPSY WAS NOT PERFORMED. FURTHER FOLLOW-UP REVEALED THAT THE PT'S FAMILY MEMBERR DID NOT WANT THE DEVICE EXPLANTED PRIOR TO BURIAL. THERE IS NO EVIDENCE THAT THE VNS THERAPY SYSTEM CAUSED OR CONTRIBUTED TO THE PT'S DEATH. REVIEW OF MFG RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 9597

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE 11/30/05| DATE OF MFG 11/5/2003, STERILIZATION LOT NO. 9493.