BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3947807 · Received July 21, 2014

    Report

    Report Number
    1644487-2014-01841
    Event Type
    Death
    Date Received
    July 21, 2014
    Date of Event
    March 18, 2005
    Report Date
    June 25, 2014
    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
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY OUTCOMES ATTRIBUTED TO ADVERSE EVENT - DEATH, CORRECTED DATA: AN ONLINE SEARCH DETERMINED THE DATE OF DEATH; THEREFORE, THIS FIELD IS BEING UPDATED. DATE OF EVENT, CORRECTED DATA: AN ONLINE SEARCH DETERMINED THE DATE OF DEATH; THEREFORE, THIS FIELD IS BEING UPDATED. AGE AT TIME OF EVENT, CORRECTED DATA: AN ONLINE SEARCH DETERMINED THE EVENT DATE; THEREFORE, THIS FIELD IS BEING UPDATED TO REFLECT THE PATIENT AGE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE PHYSICIAN ASSISTANT HAD NO KNOWLEDGE OF THE CAUSE OF DEATH. IT WAS REPORTED THAT THE PATIENT WAS LAST SEEN IN THE CLINIC IN 2002 AND THERE HAD BEEN NO FURTHER FOLLOW-UP WITH THE PATIENT. ADDITIONALLY, IT WAS REPORTED THAT THE GENERATOR HAD BEEN PROGRAMMED OFF. THE DATE OF DISABLEMENT IS UNKNOWN. IT IS LIKELY THAT THE PATIENT WAS NOT RECEIVING VNS THERAPY AT THE TIME OF DEATH. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    AN ONLINE SEARCH SHOWED THE DATE OF DEATH TO BE (B)(6) 2005. PROGRAMMING HISTORY WAS REVIEWED ON 12/08/2014. DATA IS AVAILABLE FROM (B)(6) 2002 TO (B)(6) 2004. THE LAST AVAILABLE DATA SHOWS THAT THE DEVICE WAS PROGRAMMED TO DELIVER THERAPY AT LEAST UNTIL (B)(6) 2004. A NORMAL MODE DIAGNOSTIC AND SYSTEM DIAGNOSTIC ON THIS DATE BOTH SHOWED NORMAL DEVICE FUNCTION. ATTEMPTS TO THE FUNERAL HOME FOR PRODUCT RETURN AND OBTAINING THE CAUSE OF DEATH FROM THE PATIENT¿S DEATH CERTIFICATE WERE UNSUCCESSFUL. AN IN-HOUSE SUDEP EVALUATION SHOWED POSSIBLE SUDEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425776 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 6181

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death