BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4193323 · Received October 22, 2014

    Report

    Report Number
    1644487-2014-02783
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 24, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 REPORTED THAT THE VNS PATIENT PASSED AWAY AND WAS UNDERGOING AN AUTOPSY. IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY IN HER SLEEP AND WAS FOUND THE NEXT MORNING. THE CAUSE OF DEATH IS PENDING THE FINAL DEATH CERTIFICATE COMPLETION. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS BURIED WITH THE PATIENT; THEREFORE, NO ANALYSIS CAN BE PERFORMED. THE DEATH CERTIFICATE LISTED THE CAUSE OF DEATH AS SUDDEN CARDIAC ARREST SUBSEQUENT TO DILATED CARDIOMYOPATHY. BASED ON THE AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH WAS UNLIKELY SUDEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673225 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 3181

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death