BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1001049 · Received February 22, 2008

    Report

    Report Number
    1644487-2008-00383
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS THERAPY PT EXPERIENCED AN EPISODE OF HEART BLOCK WHICH LEAD TO THE PT GOING TO THE EMERGENCY ROOM. THE TREATING PHYSICIAN'S ASSESSMENT OF WHETHER OR NOT THIS EVENT IS RELATED TO VNS THERAPY IS UNK TO MFR AT THIS TIME. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization