BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4111684 · Received September 23, 2014

    Report

    Report Number
    1644487-2014-02433
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    August 4, 2012
    Report Date
    August 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE SUPPLEMENTAL REPORT #1 INADVERTENTLY DID NOT REPORT THIS INFORMATION.

    Description of Event or Problem · 1

    THE NATIONAL DEATH INDEX DATABASE WAS REVIEWED, AND THE CAUSE OF DEATH WAS IDENTIFIED TO BE UNSPECIFIED ENCEPHALOPATHY AND UNSPECIFIED RESPIRATORY FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. A SEARCH ONLINE FOUND THE OBITUARY WHICH STATED THE PATIENT PASSED ON (B)(6) 2012 AFTER A LIFE LONG ILLNESS. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE BELIEVED CAUSE OF DEATH WAS CHRONIC RESPIRATORY FAILURE. THE CAUSE OF DEATH WAS NOT BELIEVED TO HAVE RELATIONSHIP TO VNS. THE DEVICE WAS NOT EXPLANTED AFTER DEATH. AN AUTOPSY WAS NOT PERFORMED. THE DEATH WAS WITNESSED, BUT THE DETAILS ARE UNKNOWN. THE PATIENT HAD A HISTORY OF CHRONIC RESPIRATORY INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591642 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012704

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death