BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6207787 · Received December 27, 2016

    Report

    Report Number
    1644487-2016-02950
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    September 1, 2015
    Report Date
    February 3, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP WITH THE SERVICING FUNERAL HOME SHOWED THAT THE PATIENT WAS BURIED, AND PER THEIR POLICY THAT BURIED PATIENTS DO NOT HAVE DEVICES REMOVED, THE PATIENT¿S DEVICE WAS UNAVAILABLE TO BE RETURNED. FOLLOW UP WITH THE OFFICE OF THE TREATING PHYSICIAN SHOWED THE LAST AVAILABLE SETTINGS AND DIAGNOSTICS PRIOR TO THE PATIENT¿S DEATH, WHICH WERE WITHIN NORMAL LIMITS. FOLLOW UP WITH THE HOSPITAL TENDING TO THE PATIENT AT THE TIME OF DEATH SHOWED THAT THE PATIENT WAS ADMITTED FOR ACUTE RESPIRATORY FAILURE. THE PATIENT APPEARED TO DIE FROM THE FAILURE AND SUSPECTED SEPTIC SHOCK FROM A RESPIRATORY SOURCE. THE RESPIRATORY FAILURE WAS BELIEVED TO RELATE TO CHRONIC CONGESTIVE HEART FAILURE. THE PATIENT WAS ON VENTILATION UNTIL PALLIATIVE CARE WAS INITIATED. THE PATIENT CONTINUED TO BE IN RESPIRATORY DISTRESS OF VARYING DEGREES UNTIL HIS DEATH. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. AN ONLINE OBITUARY SEARCH REVEALED THE DATE OF DEATH, BUT NO OTHER RELEVANT INFORMATION WAS STATED. THE GENERATOR AND LEAD DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND THAT ALL SPECIFICATIONS WERE MET PRIOR TO DISTRIBUTION. NO ADDITIONAL PERTINENT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856026 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016999

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death