BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 5341090 · Received January 4, 2016

    Report

    Report Number
    1644487-2016-00024
    Event Type
    Injury
    Date Received
    January 4, 2016
    Date of Event
    August 1, 2015
    Report Date
    December 10, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT THE PATIENT HAS REPORTED LEFT VOCAL CORD DYSFUNCTION. THE ONSET OF THE EVENT IS UNKNOWN. THE PATIENT HAS CONSULTED WITH AN ENT SURGEON ON WHETHER OR NOT ANY INTERVENTION NEEDS TO BE TAKEN.

    Description of Event or Problem · 1

    (B)(6) 2016 NOTES STATE THAT THE PATIENT IS HERE TO HAVE THE VNS SETTINGS DECREASED. SINCE HAVING HER DUTY CYCLE INCREASED IN AUGUST, SHE HAS BEEN EXPERIENCING PROBLEMS RELATED TO HER VNS. SHE HAS BEEN WHEEZING, HAS SHORTNESS OF BREATH, AND CANNOT TOLERATE WALKING SHORT DISTANCES OR GOING UP A FLIGHT OF STAIRS. SHE SAW AN ENT AND WAS TOLD SHE HAS VOCAL CORD DYSFUNCTION. THE MD DECREASED DUTY CYCLE FROM 35% TO 29%. (B)(6) 2016 -PATIENT LEFT TO DO STAIRS AND WALK BRISKLY; CAME BACK AND IS STILL HAVING PROBLEMS WITH WHEEZING AND SHORTNESS OF BREATH. TURNED DEVICE OFF AND REPEATED, WHEEZING AND SHORTNESS OF BREATH GONE TOTALLY. SHE FEELS MUCH BETTER. BUT WITH DEVICE OFF FEELS LIKE SHE IS HAVING MUSCLE SPASMS NEAR VAGUS NERVE, COULD FEEL THE QUIVER OF LEFT NECK WHICH ALSO AFFECTED HER SPEECH. DEVICE WAS THEN DECREASED TO 0.5 MA THEN BACK TO 1.5 MA. SO PATIENT WAS SET BACK TO 1.5 MA AND WILL BE SEEN IN A FEW WEEKS TO REDUCE IF NECESSARY. (B)(6) 2016 NOTES STATE THE HOME PULMONARY AND ENT SPECIALISTS STATE THAT THE WHEEZING WHILE EXERCISING IS RELATED TO VNS. WHEN THE VNS WAS STOPPED SHE WAS ABLE TO EXERCISE QUITE WELL WITHOUT DIFFICULTIES. THEY STATE THAT MAY INDICATE SIGNIFICANT AIRWAY OBSTRUCTION RELATED TO VAGUS NERVE STIMULATION. NOTES STATE THEY WILL GET HER DOWN TO 1 MA AND CYCLE 30 SEC ON AND 5 MIN OFF AND SEE IF THAT BECOMES MORE MANAGEABLE IN TERMS OF HER BREATHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW A LOCAL ENT AND THE NEUROLOGISTS HAVE YET TO SEE THE PATIENT IN THE OFFICE. SHE WAS NOT COMPLAINING AT ALL WHEN THEY PREVIOUSLY SAW HER. FURTHER FOLLOW-UP SHOWED THAT THE PATIENT HAS BEEN WHEEZING, HAVING SHORTNESS OF BREATH, AND DIFFICULTY WALKING SHORT DISTANCES. SHE THOUGHT HER ASTHMA WAS FLARING UP SO SHE SAW HER PRIMARY PHYSICIAN. HE NOTICED THAT THE WHEEZING WAS COMING FROM HER THROAT. SHE WAS SENT TO ENT AND HAD FURTHER TESTING DONE. SHE WAS TOLD SHE HAS VOCAL CORD DYSFUNCTION MOST LIKELY FROM THE VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1090

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other