BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 300

    MDR report key: 2852306 · Received November 30, 2012

    Report

    Report Number
    1644487-2012-03155
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    August 1, 2010
    Report Date
    November 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012 WHEN IT WAS REPORTED THAT THE VOCAL CORD PARALYSIS WAS FIRST OBSERVED IN EARLY (B)(6) 2012; EXACT DATE NOT PROVIDED. THE PHYSICIAN STATED THAT THE PATIENT WAS SEEN BY THE RADIOLOGY DEPARTMENT AND IT WAS DETERMINED ON (B)(6) 2012 THAT THE PATIENT HAS THYROID CANCER. THE PATIENT IS THEREFORE BEING TREATED FOR THYROID CANCER. THE VOCAL CORD PARALYSIS WAS NOTED TO BE NOT RELATED TO VNS STIMULATION. THE PATIENT WAS EVALUATED BY AN ENT (EAR, NOSE, AND THROAT) PHYSICIAN AND THE OUTCOME OF THE EVALUATION WAS THAT THE PATIENT HAS THYROID CANCER. THE PHYSICIAN DOES NOT THINK THE THYROID CANCER HAS ANYTHING TO DO WITH VNS. NO PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE VOCAL CORD PARALYSIS. THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF VOCAL CORD PARALYSIS PRIOR TO VNS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT RECENTLY PASSED AWAY DUE TO CANCER. THE PATIENT'S OBITUARY WAS FOUND ONLINE AND IT STATED THAT THE DATE OF DEATH WAS (B)(6) 2013. IT WAS REPORTED THAT IT WAS BELIEVED THAT THE PATIENT PASSED AWAY FROM THE THYROID CANCER AND THAT THE DEATH WAS NOT RELATED TO VNS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE VNS PATIENT WAS REFERRED TWO WEEKS PRIOR FOR AN EAR, NOSE, AND THROAT EVALUATION AS THE PATIENT WAS EXPERIENCING BILATERAL VOCAL CORD PARALYSIS AND THE NEUROLOGIST IT WAS POSSIBLY RELATED TO VNS. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. IT WAS PREVIOUSLY REPORTED THAT THE VNS PATIENT WAS DIAGNOSED BY HER EAR, NOSE, AND THROAT PHYSICIAN (ENT) WITH VOCAL CORD PARALYSIS IN (B)(6) 2010. THE ENT REPORTED TO THE NEUROLOGIST THAT THE VOCAL CORD PARALYSIS WAS VIRAL IN NATURE AND NOT RELATED TO VNS. SYSTEM DIAGNOSTICS WERE PERFORMED ON (B)(6) 2010, WHICH SHOWED THE DEVICE TO BE FUNCTIONING PROPERLY. THE NEUROLOGIST LOWERED THE PATIENT'S FREQUENCY TO SEE IF THAT WOULD AFFECT THE PATIENT, BUT DID LEAVE HER PROGRAMMED ON AS HE DID NOT BELIEVE THE PARALYSIS WAS RELATED TO VNS AT THAT TIME. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN ARE UNDERWAY BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 4813

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other