BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2063785 · Received April 15, 2011

    Report

    Report Number
    1644487-2011-00813
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN UNKNOWN MEDTRONIC'S REPRESENTATIVE THAT A PATIENT'S VAGUS NEVER STIMULATOR (VNS) DEVICE WAS BEING EXPLANTED DUE TO IMPLANTATION OF A PACEMAKER. GOOD FAITH ATTEMPTS WITH PATIENT'S CARDIOLOGIST REGARDING PATIENT'S CARDIAC ISSUES HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 2196

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention