BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3081034 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01172
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE PATIENT'S SISTER REPORTED THAT THE FAMILY IS STILL WAITING ON A CAUSE OF DEATH. AN ONLINE OBITUARY CONFIRMED THE DATE OF DEATH AS (B)(6) 2013. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181250 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 014460

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death