BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3951064 · Received July 22, 2014

    Report

    Report Number
    1644487-2014-01848
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    February 2, 2009
    Report Date
    June 27, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: INITIAL REPORT INDICATED THE PATIENT'S AGE WAS 20 YEARS AT THE TIME OF DEATH HOWEVER IT WAS (B)(6) YEARS. THE INFORMATION HAS BEEN CORRECTED IN THIS REPORT. DATE OF EVENT: INITIAL REPORT INDICATED THE DATE OF THE EVENT WAS (B)(6) 2014 HOWEVER IT WAS (B)(6) 2009 (DATE OF DEATH). THE INFORMATION HAS BEEN CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. BASED ON THE LIMITED AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH MAY BE POSSIBLE SUDEP.

    Description of Event or Problem · 1

    THE PATIENT¿S OBITUARY WAS LOCATED AND THE DATE OF DEATH WAS OBTAINED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL DETAILS SURROUNDING THE PATIENT¿S DEATH HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427921 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010904

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death