BEUDAMED
    FDA Adverse Event Death Summary report: N

    VNS THERAPY PULSE

    MDR report key: 581134 · Received March 14, 2005

    Report

    Report Number
    1644487-2005-00147
    Event Type
    Death
    Date Received
    March 14, 2005
    Date of Event
    February 11, 2005
    Report Date
    February 17, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THT VNS PT HAD PASSED AWAY. THE PT REPORTEDLY DIED WHILE HOME ALONE AND WAS FOUND FACE DOWN ON BED. DEATH CERTIFICATE LISTS CARDIOPLUMONARY ARREST, DUE TO OR AS A CONSEQUENCE OF MENTAL RETRACTATION, DUE TO OR AS A CONSEQUENCE OF EPILEPSY AS THE CAUSE OF DEATH. IT WAS REPORTED THAT THE PT EXPERIENCED A >25% REDUCTION IN SEIZURES WITH THE VNS THERAPY AND THAT PT WAS RECEIVING THERAPY AT THE TIME OF DEATH. NO AUTOPSY WAS PERFORMED. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE. THERE IS NO EVIDENCE AT THIS TIME THAT THE VNS THERAPY SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 6776

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death DATE OF MFG 08/21/02, STERILIZATION LOT #6883| MODEL 302-20 VNS THERAPY LEAD EXPIR DATE 08/31/04