BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1672724 · Received April 30, 2010

    Report

    Report Number
    1644487-2010-01059
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    June 19, 2006
    Report Date
    April 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PT WAS FOUND TO BE DECEASED DUE TO UNKNOWN REASON. THE PT'S DATE OF DEATH WAS FOUND TO BE IN (B) (6) 2006 PER THE DEATH INDEX. FURTHER INFO REVEALED THE PT HAD UNDERGONE VNS REPLACEMENT OF THE GENERATOR IN 2003 DUE TO SUSPECTED END OF SERVICE. MOREOVER, THE PT'S LEAD WAS ALSO REPLACED AT THE SAME TIME AS THE GENERATOR DUE TO UNK REASON. ADD'L INFO WAS RECEIVED FROM THE NEUROLOGIST'S OFFICE INDICATING THE PT'S CHART WAS NOT AVAILABLE TO FURTHER PROVIDE INFO, AS IT WAS LOCATED IN OFF-SITE STORAGE AND STAFF WAS NOT AVAILABLE TO RETRIEVE THE CHART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 6288

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death