BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 695728 · Received April 4, 2006

    Report

    Report Number
    1644487-2006-00173
    Event Type
    Other
    Date Received
    April 4, 2006
    Date of Event
    February 2, 2005
    Report Date
    March 6, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT HAD PASSED AWAY. CAUSE OF DEATH IS UNK AT THIS TIME AS NO RESPONSE HAS BEEN RECEIVED TO MANUFACTURER'S REQUESTS FOR ADDITIONAL INFORMATION FROM TREATING PHYSICIAN. THERE IS NO EVIDENCE AT THIS TIME THAT HTE NCP SYSTEM CAUSED OF CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ LYJ CYBERONICS, INC. 101 40548C

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other