BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2194537 · Received August 1, 2011

    Report

    Report Number
    1644487-2011-01742
    Event Type
    Death
    Date Received
    August 1, 2011
    Date of Event
    August 10, 2008
    Report Date
    July 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011 THE PATIENT'S DEATH CERTIFICATE WAS RECEIVED. THE DEATH CERTIFICATE STATED THAT THE CAUSE OF DEATH WAS CARDIORESPIRATORY ARREST AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO THE DEATH WERE LISTED AS SEIZURES/EPILEPSY. IF FURTHER INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN'S NURSE REPORTED THAT THE VNS PT PASSED AWAY ON (B)(6) 2008. NO FURTHER INFO REGARDING THE PT'S DEATH WAS PROVIDED AT THAT TIME. THE PT'S PHYSICIAN PASSED AWAY THE WEEK OF (B)(6) 2011 AND THE PHYSICIAN'S NURSE QUIT; THEREFORE, THE MANUFACTURER'S CONSULTANT WAS ONLY ABLE TO OBTAIN THE PT'S CLINIC NOTES FROM THEIR MEDICAL RECORDS AND HAD NO MEDICAL PROFESSIONAL TO F/U WITH. THE PT'S CLINIC NOTES WERE REC'D WHICH REVEALED THAT THE PT'S LAST VISIT WAS ON (B)(6) 2008. THE PT'S SETTINGS THAT DATE WERE OUTPUT= 2.75MA/FREQUENCY=20HZ/ PULSE WIDTH = 130USEC/ON TIME=60SEC/ OFF TIME=1.1MIN/MAGNET OUTPUT=3MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC. A SYSTEM'S DIAGNOSTIC TEST PERFORMED THAT DAY SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=2/ERI=NO. THE CLINIC NOTES REVEAL THAT THE PT HAD A MYOCARDIAL INFARCTION AS WELL AS CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN THE PAST AND HAS A STRONG FAMILY HISTORY OF HEART DISEASE. IT IS UNK IF THESE EVENTS ARE RELATED TO THE PT'S DEATH OR NOT. THE PT'S DEATH CERTIFICATE WILL BE REQUESTED FROM THE STATE THE PT PASSED AWAY IN. WHEN ADD'L INFO IS REC'D, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 2375

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death