BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4222211 · Received November 3, 2014

    Report

    Report Number
    1644487-2014-02908
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    July 22, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    PATIENT DEATH CERTIFICATE IS UNABLE TO BE OBTAINED PER STATE LAW. GOOD FAITH ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE FUNERAL HOME REPORTED THAT THE DEVICES ARE BELIEVED TO NOT HAVE BEEN REMOVED FROM THE PATIENT. BASED ON THE AVAILABLE INFORMATION, A REVIEW BY THE DEVICE MANUFACTURER WAS PERFORMED, AND THE DEATH IS CLASSIFIED AS POSSIBLE SUDEP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VNS PATIENT PASSED AWAY ON (B)(6) 2014. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. ATTEMPTS TO OBTAIN FURTHER RELEVANT INFORMATION WILL BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702822 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010436

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death