BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4844290 · Received June 15, 2015

    Report

    Report Number
    1644487-2015-04895
    Event Type
    Death
    Date Received
    June 15, 2015
    Report Date
    May 20, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE PHYSICIAN DID NOT KNOW THE CAUSE OR DATE OF DEATH. THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388207 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 2740

    Patients

    Seq Age Sex Outcome Treatment
    1 Death