BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6003184 · Received October 6, 2016

    Report

    Report Number
    1644487-2016-02275
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 13, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE PROCESS OF BEING SCHEDULED FOR A GENERATOR REPLACEMENT WHEN IT WAS REPORTED THAT SHE PASSED AWAY. THE CAUSE OF DEATH WAS NOT KNOWN AT THE TIME OF THE REPORT. THE FUNERAL HOME REPORTED THAT THE GENERATOR WAS EXPLANTED AFTER THE PATIENT'S PASSING AND THE PATIENT'S FAMILY KEPT THE DEVICE. THEREFORE IT IS NOT EXPECTED BACK FOR PRODUCT ANALYSIS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS NOT KNOWN; THEREFORE, SHE COULD NOT ASSESS THE RELATIONSHIP OF THE PATIENT'S DEATH TO VNS THERAPY. IT WAS REPORTED THAT THE PATIENT WAS ON VNS THERAPY AT THE TIME OF HER PASSING AND WAS BEING REFERRED FOR A PROPHYLACTIC REPLACEMENT AT THAT TIME. THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED A REDUCTION IN SEIZURES AS RESULT OF VNS THERAPY. SHE HAD A HISTORY OF BEING COMPLIANT WITH HER ANTIEPILEPTIC MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658809 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015484

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death