BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUL GEN MODEL UNK

    MDR report key: 1120663 · Received August 14, 2008

    Report

    Report Number
    1644487-2008-01907
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    October 1, 1999
    Report Date
    July 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: ASCONAPE, JORGE J., DAVID D. MOORE, DOUGLAS P. ZIPES, LAURA M. HARTMAN, AND WILLIAM H. DUFFELL. "BRADYCARDIA AND ASYSTOLE WITH THE USE OF VAGUS NERVE STIMULATION FOR THE TREATMENT OF EPILEPSY: A RARE COMPLICATION OF INTRAOPERATIVE DRUG TESTING." EPILEPSIA 40 (1999): 1452-1454.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE SUCCESSIVE INTRAOPERATIVE DIAGNOSTIC TESTS PERFORMED ON A VNS PT RESULTED IN MULTIPLE ARRHYTHMIA EVENTS. THE FIRST TWO TESTS RESULTED IN BRADYCARDIA, WHERE THE THIRD RESULTED IN TRANSIENT ASYSTOLE WHICH REQUIRED ATROPINE AND BRIEF CARDIOPULMONARY RESUSCITATION. THE PROCEDURE WAS TERMINATED, THE DEVICE WAS REMOVED, AND THE PT RECOVERED COMPLETELY. THE REPORTER INDICATED THAT THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND IT WAS FOUND TO BE FUNCTIONING PROPERLY. GOOD FAITH ATTEMPTS FOR ADDITIONAL PRODUCT/PATIENT INFO ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R