BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1132649 · Received August 22, 2008

    Report

    Report Number
    1644487-2008-01997
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    November 30, 2007
    Report Date
    July 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT EXPERIENCED "POST OPERATIVE LARYNGOSPASM WITH RESPIRATORY ARREST TREATED WITH OXYGEN AND NALOXONE AND DIPHENHYDRAMINE. BRIEF RESPIRATORY ARREST FROM LARYNGOSPASM DURING HER TRANSFER TO THE RECOVERY ROOM TREATED WITH NALOXONE AND OXYGEN. DIPHENHYDRAMINE WAS ALSO GIVEN AS SHE HAD A (PREEXISTING) THORACIC RASH." THE MEDICAL PROFESSIONAL STATED THE EVENT WAS DEFINITIVELY RELATED TO VNS THERAPY IMPLANTATION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 200471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R