BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4203239 · Received October 27, 2014

    Report

    Report Number
    1644487-2014-02838
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    April 22, 2011
    Report Date
    October 7, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD PASSED AWAY. THE DEATH WAS UNEXPECTED. THE PATIENTS GENERATOR WAS AT END OF SERVICE AT THE TIME OF DEATH AND CLINIC NOTES DATED 2 WEEKS PRIOR TO HIS DEATH NOTED THAT HE HAD THE BEST SEIZURE CONTROL THAT HE HAS EVER HAD IN HIS LIFE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THE PATIENT PASSED AWAY FROM SUDDEN UNEXPLAINED DEATH IN EPILEPSY (SUDEP), AND THE PHYSICIAN'S OFFICE DOES NOT BELIEVE THAT THE PATIENT'S DEATH WAS RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683637 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 010220

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death