BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 5694647 · Received June 2, 2016

    Report

    Report Number
    1644487-2016-01209
    Event Type
    Death
    Date Received
    June 2, 2016
    Date of Event
    May 7, 2016
    Report Date
    May 9, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INITIAL MDR INADVERTENTLY DID NOT INCLUDE THIS INFORMATION.

    Description of Event or Problem · 1

    A PROVIDER REPORTED THAT A VNS PATIENT EXPIRED FROM AN UNKNOWN CAUSE AND WAS FOUND LATE ON THE EVENING OF (B)(6) 2016 AND APPARENTLY HAD BEEN DEAD FOR A WEEK. THE PROVIDER STATED SHE HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE CAUSE OF DEATH. FOLLOW UP WITH THE MEDICAL EXAMINER INDICATED THEY THE OFFICIAL DATE OF DEATH WAS RECORDED AS (B)(6) 2016. THE MEDICAL EXAMINER STATED THAT NO FURTHER INFORMATION OF ANY KIND, SUCH AS CAUSE OF DEATH OR FUNERAL HOME INFORMATION, COULD BE RELEASED WITHOUT A SIGNED RELEASE FROM THE IMMEDIATE NEXT OF KIN. FOLLOW UP WITH HEALTHCARE PROVIDER INDICATED THEY WERE INFORMED OF THE PATIENT'S DEATH BY A LOCAL POLICEMAN WHO INDICATED THAT LIFE SAVING MEASURES WERE ATTEMPTED BUT WERE UNSUCCESSFUL AS IT APPEARED THE PATIENT HAD BEEN DEAD APPROXIMATELY A WEEK. THE PROVIDER INDICATED THE POSSIBILITY OF SUDEP WAS INCREASED IN THIS PATIENT DUE TO A HISTORY OF MYOCLONIC AND GENERALIZED SEIZURES, MEDICALLY RESISTANT GENERALIZED EPILEPSY WITH COGNITIVE IMPAIRMENT. THE PATIENT DID NOT HAVE A HISTORY OF RESECTIVE SURGERY AND AGE OF ONSET OF SEIZURES WAS (B)(6) FROM AN UNKNOWN REASON. VNS SETTINGS AT THE MOST RECENT VISIT WERE TYPICAL FOR VNS PATIENTS WITH DEVICE DIAGNOSTICS WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEIZURE REDUCTION WITH VNS THERAPY. THE PROVIDER WAS UNSURE OF THE RELATION OF THE DEATH TO VNS THERAPY. AN INTERNAL SUDEP ANALYSIS INDICATES THAT THE DEATH WAS POSSIBLY RELATED TO SUDEP.

    Description of Event or Problem · 1

    REVIEW OF AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY REVEALED NO ANOMALIES AND A BATTERY LIFE CALCULATION PERFORMED WITH AVAILABLE DATA INDICATES THE DEVICE HAD 4.5 YEARS REMAINING UNTIL NEOS = YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349751 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202943

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death