BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2133424 · Received June 15, 2011

    Report

    Report Number
    1644487-2011-01326
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S PARENT THAT THE PT WAS EXPERIENCING BREATHING PROBLEMS AND NUMBNESS OF HER LIPS. THE PT WAS SEEN BY HER FAMILY PHYSICIAN, WHO SAID HER LUNGS SOUNDED CLEAR. A X-RAY WAS PERFORMED AND NOTHING ABNORMAL WAS SEEN AT THIS TIME. EVEN USE OF A RESCUE INHALER WAS NOT BENEFICIAL. DIAGNOSTIC TESTING ON (B)(6) 2010 REVEALED NORMAL DEVICE FUNCTION, AND THE DEVICE HAD JUST BEEN RECENTLY IMPLANTED. F/U WITH THE PT'S PHYSICIAN INDICATED THAT NEITHER THE DYSPNEA NOR THE NUMBNESS WAS RELATED TO VNS. THE NUMBNESS WAS STATED TO HAVE FIRST OCCURRED ON (B)(6) 2011. LAST KNOWN SETTINGS FROM (B)(6) 2011 WERE 0.75MA, 20 HZ, 250MICROSEC, 60 SEC, 1.8 MIN, 1.00 MA, 60 SEC, 500 MICRO SEC. LATER INFO SHOWED THAT THE PT HAD UNDERGONE MORE TESTING BY AN ENT DOCTOR, WHO SAW THAT THE PT'S TONSILS AND ADENOIDS WERE ABNORMALLY LARGE AND HER LEFT VOCAL CORD WAS PARTIALLY PARALYZED. HE ALSO SUGGESTED REMOVAL OF THE ADENOIDS AND TONSILS. THE PT'S VNS PHYSICIAN, THOUGH, DID NOT FEEL THAT THE ADENOID AND TONSIL ISSUES WERE RELATED TO VNS WHATSOEVER, THOUGH IT WAS CAUSING THE BREATHING AND OTHER ISSUES PREVIOUSLY REPORTED. IT WAS NOT KNOWN HOW THE VNS AFFECTED THE PARALYSIS EVENT, THOUGH. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE CAUSED THE VOCAL CORD PARALYSIS IN THE PATIENT. THE ONSET OF VOCAL CORD PARALYSIS IS UNKNOWN. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2767

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other