BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 5374081 · Received January 18, 2016

    Report

    Report Number
    1644487-2016-00099
    Event Type
    Death
    Date Received
    January 18, 2016
    Date of Event
    December 19, 2015
    Report Date
    December 21, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PROVIDER INDICATED THAT NO OTHER CAUSE OF DEATH IS SUSPECTED AND THE DEATH REMAINS CLASSIFIED AS PROBABLE SUDEP. THE PROVIDER INDICATED THAT THE PATIENT EXPERIENCED A SEIZURE THE NIGHT BEFORE HIS DEATH BUT THEN WENT TO BED AS USUAL AND DIED IN HIS SLEEP. THE FUNERAL HOME INDICATED THEY DID NOT KNOW IF THE DEVICE HAD BEEN REMOVED PRIOR TO CREMATION. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE FUNERAL HOME HAVE BEEN UNSUCCESSFUL TO DATE. THE PATIENT IS IDENTIFIED ON THE RESPECTIVE COUNTY MEDICAL EXAMINER WEBSITE, HOWEVER, CAUSE OF DEATH AND MANNER OF DEATH STATUS IS INDICATED TO BE PENDING.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE MEDICAL EXAMINER INDICATED THAT THE CAUSE OF DEATH DETERMINATION REMAINS PENDING AND A PROJECTED DATE OF AVAILABILITY WAS NOT ABLE TO BE PROVIDED. A WRITTEN REQUEST WAS MADE TO THE MEDICAL EXAMINER FOR THE DEATH CERTIFICATE OR AUTOPSY REPORT TO BE PROVIDED ONCE AVAILABLE. THE MEDICAL EXAMINER WAS UNABLE TO PROVIDE THE STATUS OF THE IMPLANTED DEVICE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE MEDICAL EXAMINER SUBSEQUENTLY REPORTED THAT THE DEVICE WAS REMOVED (EXPLANTED) AND PROVIDED TO THE FUNERAL HOME ON OR AROUND (B)(4) 2015. WHEN CONTACTING THE FUNERAL HOME, THE FUNERAL HOME INDICATED THAT THE EXPLANTED DEVICE WAS LIKELY PROVIDED TO THE FAMILY AS THEY NO LONGER HAVE IT IN THEIR POSSESSION.

    Description of Event or Problem · 1

    A PROVIDER REPORTED THAT A VNS PATIENT HAD PASSED AWAY AND STATED THAT SUDEP WAS THE PROBABLE CAUSE OF DEATH. THE PATIENT PASSED AWAY DURING HIS SLEEP AND NO OTHER KNOWN CAUSE OF DEATH HAS BEEN IDENTIFIED TO DATE. THE PROVIDER STATED THAT THE DEATH WAS NOT RELATED TO THE VNS SYSTEM. REVIEW OF AVAILABLE PROGRAMMING AND DIAGNOSTIC DATA INDICATE TYPICAL VNS SETTINGS AND NORMAL DIAGNOSTIC DATA WITHIN NORMAL LIMITS THROUGH (B)(6) 2015. A BATTERY LIFE CALCULATION PERFORMED WITH THE AVAILABLE PROGRAMMING AND DIAGNOSTIC DATA INDICATED OVER 10 YEARS UNTIL NEOS WOULD BE REACHED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33354 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3620

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death