BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4090690 · Received September 15, 2014

    Report

    Report Number
    1644487-2014-02349
    Event Type
    Death
    Date Received
    September 15, 2014
    Date of Event
    December 25, 2005
    Report Date
    May 20, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD PASSED AWAY. THE PHYSICIAN THAT REPORTED THIS TO THE MANUFACTURER WAS NOT CURRENTLY TREATING THE PATIENT, HE HAD JUST HEARD THAT THEY PASSED AWAY. THERE WAS NO REASON GIVEN OR NO SPECULATION FROM THE PHYSICIAN. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569765 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 010275

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death