BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6122170 · Received November 22, 2016

    Report

    Report Number
    1644487-2016-02715
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    October 28, 2016
    Report Date
    April 6, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN PROVIDED THE PATIENT'S DEVICE SETTINGS, BUT DIAGNOSTIC RESULTS WERE NOT PROVIDED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO FEELING SICK AND HAVING A FEW SEIZURES, WHICH WERE NOT ALLEGED TO BE RELATED TO THE PATIENT'S VNS. THE PATIENT WAS INTUBATED AND EXPERIENCED CARDIAC ARREST WHILE IN THE EMERGENCY DEPARTMENT. THE PATIENT WAS THEN TRANSFERRED TO THE ICU, AND A BRAIN MRI WAS SCHEDULED. IT WAS LATER REPORTED THAT THE PATIENT WAS PLACED ON LIFE SUPPORT ON (B)(6) 2016 AND WAS DEEMED BRAIN DEAD. THE PATIENT PASSED AWAY ON (B)(6) 2016, AND THE DEVICE WAS NOT EXPLANTED. ATTEMPTS FOR FURTHER INFORMATION WERE UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE DEATH SUMMARY FROM THE PATIENT'S HOSPITALIZATION WAS PROVIDED. THE PATIENT PRESENTED AT THE EMERGENCY ROOM AFTER HE HAD A SEIZURE, ADMINISTERED ATIVAN, AND WAS TAKEN TO THE HOSPITAL BY EMERGENCY MEDICAL SERVICES. THE PATIENT HAD A HISTORY OF SEIZURE DISORDERS AND DEVELOPMENTAL DELAY. THE PATIENT ALSO HAD A URINARY TRACT INFECTION. THE INITIAL ASSESSMENT UPON THE PATIENT'S ARRIVAL WAS ENCEPHALOPATHY POSTANOXIC, POSTICTAL CARDIAC ARREST, PULSELESS ELECTRICAL ACTIVITY (PEA), POSTANOXIC MYOCLONUS, STATUS EPILEPTICUS, ACUTE RESPIRATORY FAILURE, AND ELEVATED HEPATIC ENZYMES. THE PATIENT WAS GIVEN ANTIEPILEPTIC MEDICATIONS WHILE IN THE HOSPITAL. THE PATIENT ALSO HAD EVIDENCE OF KIDNEY INJURY, AND THE ASSESSMENT WAS ACUTE KIDNEY INJURY, METABOLIC ACIDOSIS, AND ANEMIA. THE PATIENT WAS IN THE ICU, AND THE ASSESSMENT WAS THAT THE PATIENT HAD RESPIRATORY TO CARDIAC ARREST, SECONDARY TO SEIZURE AND ATIVAN ADMINISTRATION. A CHEST X-RAY REVEALED A LEFT LOWER LOBE INFILTRATE AND PRESUMPTIVE PNEUMONIA. SUBSEQUENT TO THIS, THE PATIENT REMAINED IN AN ANOXIC STATE AND VENTILATOR DEPENDENT. AN MRI WAS PERFORMED, WHICH WAS CONSISTENT WITH ANOXIC BRAIN INJURY. THE PATIENT'S FAMILY AND PHYSICIANS DECIDED TO REMOVE THE PATIENT FROM LIFE SUPPORT, AND THE PATIENT PASSED AWAY DUE TO RESPIRATORY FAILURE SECONDARY TO ANOXIC ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773160 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 203712

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death