BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1790928 · Received August 3, 2010

    Report

    Report Number
    1644487-2010-01791
    Event Type
    Death
    Date Received
    August 3, 2010
    Date of Event
    July 30, 2006
    Report Date
    July 12, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A VNS PATIENT'S WIFE CALLED AND REPORTED TO MANUFACTURER THAT HER HUSBAND HAD DIED FROM THE STROKE AND THAT DEATH WAS NOT VNS RELATED. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS SURROUNDING THE PATIENT'S REPORTED DEATH AND RELATIONSHIP TO THEIR VNS FROM THEIR TREATING PHYSICIAN AT THE TIME. THUS FAR GOOD FAITH ATTEMPTS HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 7109

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death