BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2730000 · Received September 6, 2012

    Report

    Report Number
    1644487-2012-02238
    Event Type
    Death
    Date Received
    September 6, 2012
    Date of Event
    July 6, 2012
    Report Date
    August 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED. THE PATIENT'S SETTINGS ON (B)(6) 2012, WERE OUTPUT=2.5MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=2.75MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC/NEOS=NO. SYSTEM AND NORMAL MODE DIAGNOSTICS PERFORMED THAT SAME DAY SHOWED THE DEVICE TO BE FUNCTIONING PROPERLY WITH OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=2/NEOS=NO AND OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=5/NEOS=NO RESPECTIVELY. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS SUDEP AND THE DEATH WAS NOT RELATED TO VNS. THERE WERE NO RECENT LABORATORY REPORTS OR FINDINGS CONSIDERED RELEVANT TO THE CAUSE OF DEATH. THE PATIENT WAS FOUND PASSED AWAY BESIDE HIS BED AT HOME THE MORNING OF (B)(6) 2012. THE PATIENT WAS LYING ON THE FLOOR, POSITION UNKNOWN. THE PATIENT DID HAVE A HISTORY OF NOCTURNAL SEIZURES. IN THE LAST MONTH THE PATIENT AVERAGED 10 SIMPLE PARTIAL SEIZURES, 1-2 2ND GENERALIZED SEIZURES, 10 COMPLEX PARTIAL SEIZURES, AND 10 MYOCLONIC SEIZURES. THE PATIENT HAS NOT EVERY UNDERGONE RESECTIVE EPILEPSY SURGERY. THE PATIENT DOES NOT HAVE A HISTORY OF DRUG OR ALCOHOL ABUSE AND THE PATIENT DOESN'T HAVE A HISTORY OF CARDIAC OR RESPIRATORY PROBLEMS. NO AUTOPSY WAS PERFORMED AND THE DEATH WAS NOT WITNESSED. THE PATIENT HAS TAKEN LEVETIRACETRAM, VIGABATRIN, VALPROATE/VALPROIC ACID, PHENYTOIN, BENZODIAZEPENES, LAMOTRIGINE, CLOBAZAM, AND TOPIRAMATE ANTI-EPILEPTIC MEDICATIONS IN THE PAST. THE PATIENT WAS CURRENTLY TAKING TOPIRAMATE, LEVETIRACETRAM, AND VIGABATRIN. THE PATIENT WAS COMPLIANT WITH AEDS. THE LAST KNOWN DRUG LEVELS ARE UNKNOWN.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT WAS FOUND DECEASED BESIDE HIS BED AT HOME IN THE MORNING ON (B)(6) 2012. THE DEATH WAS NOT WITNESSED. AN AUTOPSY WILL NOT BE PERFORMED. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200611

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death