BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4111658 · Received September 23, 2014

    Report

    Report Number
    1644487-2014-02434
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    May 2, 2008
    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
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE INITIAL MANUFACTURER REPORT INADVERTENTLY DID NOT INCLUDE INFORMATION FROM THE AUTOPSY REPORT.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS EITHER BURIED WITH THE PATIENT IF IT WAS NOT EXPLANTED OR DISCARDED IF IT WAS EXPLANTED.

    Description of Event or Problem · 1

    THE VNS PATIENT¿S DEATH CERTIFICATE WAS RECEIVED INDICATING THAT THE PATIENT PASSED AWAY AT THE HOSPITAL. THE CAUSE OF DEATH WAS LISTED AS PNEUMONIA DUE TO STATIC ENCEPHALOPATHY FROM LENNOX GASTAUT SYNDROME. THE MANNER OF DEATH WAS LISTED AS NATURAL AND NO AUTOPSY WAS PERFORMED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2008. NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591870 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 011190

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death