BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 6012904 · Received October 7, 2016

    Report

    Report Number
    1644487-2016-02290
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    January 5, 2013
    Report Date
    September 12, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OBITUARY WAS FOUND STATING THE PATIENT HAD PASSED AWAY ON (B)(6) 2013. IT WAS NOTED THE PATIENT PASSED AWAY IN THE HOSPITAL; HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE. THE IN-HOUSE PROGRAMMING HISTORY DATABASE WAS REVIEWED AND NO ANOMALIES WERE NOTED. THE DEVICE WAS FOUND TO BE WORKING AS EXPECTED THROUGH (B)(6) 2012. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH ESTIMATED THE DEVICE HAD APPROXIMATELY 0 YEARS REMAINING UNTIL NEOS = YES (NEAR END OF SERVICE). ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED FROM THE EMERGENCY DEPARTMENT PHYSICIAN THAT THE PATIENT HAD ARRIVED IN A PULSELESS ARREST WHO WAS FOUND DOWN BY HIS FAMILY MEMBERS. IT WAS NOTED THE PATIENT WAS COLD AT THE TIME THAT THEY FOUND HIM AND HE COULD HAVE BEEN DOWN FOR ANYWHERE BETWEEN 30 MINUTES TO AN HOUR. EMERGENCY INTERVENTIONS WERE TAKEN IN ORDER TO ATTEMPTS TO RESUSCITATE THE PATIENT; HOWEVER, IT WAS LATER DECIDED TO WITHDRAW CARE. THE PHYSICIAN NOTED THAT HE FELT A MEDICAL EXAMINER WAS NOT NEEDED. THE CAUSE OF THE PATIENT'S DEATH WAS RULED AS PNEUMONIA/RESPIRATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661781 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 200776

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death