BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4917534 · Received July 16, 2015

    Report

    Report Number
    1644487-2015-05205
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 22, 2015
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461962 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS 102R 1991

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death