BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2960148 · Received February 13, 2013

    Report

    Report Number
    1644487-2013-00398
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    June 20, 2012
    Report Date
    January 31, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT EXPERIENCED WHEEZING WITH VNS STIMULATION. DISABLING THE VNS WITH THE MAGNET DID HELP WITH THE WHEEZING, BUT THE PATIENT'S SEIZURES INCREASED SO THE PATIENT WAS NOT COMFORTABLE LEAVING THE VNS DISABLED WITH THE MAGNET. THE WHEEZING IS DESCRIBED AS AUDIBLE UPON INSPIRATION. THE WHEEZING OCCURS WITH VNS STIMULATION AND AN INCREASE IN EXERCISE. NO VNS PROGRAMMING CHANGES OR MEDICATION CHANGES PRECIPITATED THE WHEEZING, AND THE PATIENT DID NOT HAVE A PRE-VNS HISTORY OF WHEEZING. THE VNS SETTINGS WERE LOWERED, WHICH HELPED THE WHEEZING. THE VNS WAS LATER DISABLED AS RECOMMENDED BY A PULMONOLOGIST, TO PRECLUDE A SERIOUS INJURY TO THE PATIENT'S PULMONARY SYSTEM. THE PATIENT WAS INITIALLY PLACED ON INHALERS AND STEROIDS WHICH DID NOT RESOLVE THE WHEEZING, SO THE VNS WAS DISABLED. THE WHEEZING HAS RESOLVED SINCE THE VNS WAS DISABLED, HOWEVER; THE VNS MAY BE TURNED BACK ON AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63772 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 200843

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention