BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6043101 · Received October 20, 2016

    Report

    Report Number
    1644487-2016-02409
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 7, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VNS PATIENT HAD ASYSTOLE ON SYSTEM DIAGNOSTIC TEST PERFORMED DURING VNS SYSTEM IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ASYSTOLE EPISODE OCCURRED ON FIRST SYSTEM DIAGNOSTIC CHECK IN THE OR. IT WAS REPORTED THAT THE VNS SYSTEM WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED BY NURSE THAT IT'S UNKNOWN IF PATIENT HAD PRE VNS HISTORY OF CARDIAC EVENTS, ALTHOUGH SLOW HEART RATE NOTED. MEDICAL PROFESSIONAL OPINION ABOUT THE POSSIBLE CAUSE OF THE CARDIAC EVENT IS IRRITATION OF THE VAGUS NERVE FOLLOWING PROLONGED MANIPULATION TO HAVE OLD LEAD REMOVED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT'S VNS SYSTEM HAS BEEN SUCCESSFULLY TURNED ON AND RECENTLY INCREASED IN CLINIC WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694344 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 203814

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening