BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6082536 · Received November 7, 2016

    Report

    Report Number
    1644487-2016-02576
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    August 31, 2016
    Report Date
    October 14, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    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

    PER AN ONLINE OBITUARY THAT THE PATIENT PASSED AWAY ON (B)(6) 2016. AN AUTOMATIC BATTERY LIFE CALCULATION WAS PERFORMED WITH THE AVAILABLE DATA AND WORST CASE ASSUMPTIONS MADE FOR THE GAPS. THE DEVICE HAD AN ESTIMATED 0.4 YEARS OF LIFE REMAINING ON THE DATE OF DEATH (B)(6) 2016. THEREFORE IT CANNOT BE DETERMINED WHETHER THE DEVICE WAS STILL FUNCTIONING AT THE TIME OF DEATH PER THE DEATH CERTIFICATE THE PATIENT PASSED AWAY FROM ANOXIC BRAIN INJURY. ADDITIONAL CONDITIONS LISTED WERE ACUTE ENCEPHALOPATHY, RESPIRATORY FAILURE, HYPOXEMIC, P AND A ARREST AND HYPOTHERMIC PROTOCOL ETIOLOGY UNKNOWN. OTHER CONDITIONS LISTED WERE COPD, SEIZURE DISORDER, AND ASPIRATION PNEUMONIA. THERE WAS AN ADDITIONAL CONDITION LISTED, BUT IT WAS ILLEGIBLE. THE DEATH WAS NOTED AS NATURAL. THE DEVICE WAS DISCARDED BY THE FUNERAL HOME. THE PATIENT'S PHYSICIAN HAD NOT SEEN THE PATIENT SINCE (B)(6) 2015 AND HAD NO ADDITIONAL RELEVANT INFORMATION PERTAINING TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733220 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS - HOUSTON 102 010388

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death