BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2160854 · Received July 7, 2011

    Report

    Report Number
    1644487-2011-01518
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS REFERRED TO CARDIOLOGY AFTER GOING TO THE EMERGENCY ROOM DUE TO SINUS BRADYCARDIA. THE REPORTER BELIEVED THAT THE DEVICE MAY BE CAUSING THE PROBLEM. DIAGNOSTIC RESULTS FROM THE TIME OF THE EVENT WERE NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 201158

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention