BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1120739 · Received August 15, 2008

    Report

    Report Number
    1644487-2008-01919
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    January 1, 2004
    Report Date
    July 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "COMPLETE HEART BLOCK WITH VENTRICULAR ASYSTOLE DURING LEFT VAGUS NERVE STIMULATION FOR EPILEPSY." EPILEPSY & BEHAVIOR 5 (2004) 768-771.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE THAT DURING INITIAL VNS PLACEMENT, AN INTRAOPERATIVE SYSTEM DIAGNOSTIC TEST PRODUCED A 15-S PERIOD OF COMPLETE HEART BLOCK WITH VENTRICULAR ASYSTOLE. THE STIMULATION WAS STOPPED WITH NORMALIZATION OF HEART RATE AND RHYTHM. A SECOND DIAGNOSTICS TEST PRODUCED THE SAME CONDUCTION DEFECT. VNS WAS REMOVED. POSTOPERATIVE ECG, ECHOCARDIOGRAM, AND CARDIAC EVAL WERE UNREMARKABLE. MEDICAL RECORDS OF THE PT REVEALED NO PRIOR HISTORY OF CARDIAC DISEASE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other