BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4151688 · Received October 8, 2014

    Report

    Report Number
    1644487-2014-02580
    Event Type
    Death
    Date Received
    October 8, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. NO FURTHER INFORMATION RELEVANT TO THE EVENT HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    ATTEMPTS MADE FOR ADDITIONAL RELEVANT INFORMATION REGARDING PATIENT'S DEATH WERE UNSUCCESSFUL. A COPY OF THE DEATH CERTIFICATE COULD NOT BE OBTAINED AS THE STATE ONLY ISSUES DEATH CERTIFICATES TO IMMEDIATE FAMILY MEMBERS. AN INTERNAL SUDEP EVALUATION WAS PERFORMED BY THE MANUFACTURER WHICH DETERMINED THE DEATH TO BE POSSIBLE SUDEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633402 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 14628

    Patients

    Seq Age Sex Outcome Treatment
    1 Death