BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2904573 · Received January 9, 2013

    Report

    Report Number
    1644487-2013-00109
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 17, 2012
    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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 CLINIC NOTES WERE RECEIVED FROM A VNS TREATING PHYSICIAN. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2012 INDICATED THAT THE PATIENT HAS BEEN HAVING HOARSENESS AND DIFFICULTY SWALLOWING SINCE THE RECENT FULL REVISION SURGERY. THE PATIENT HAS CLEAR DYSPHONIA AND INCREASED WEAKNESS OF THE LEFT ARM. THE PHYSICIAN REPROGRAMMED THE DEVICE AT 0.25MA AND 0MA WHICH DID NOT CHANGE ANYTHING. THE PHYSICIAN STATED THAT HE THINKS THIS IS JUST A POSTSURGICAL DISTURBANCE OF THE VAGAL NERVE. THEY DECIDED TO TURN THE VNS FOR TWO WEEKS AND THEN HAVE THE VNS TURNED BACK ON IN THE HOPE THAT THERE WILL BE SOME HEALING GOING ON. THE PHYSICIAN REPORTED THAT THE PATIENT HAS DAMAGE TO HER VAGAL NERVE AND IS EXPERIENCING VOCAL CORD PARALYSIS. PREVIOUSLY IT HAD BEEN REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASED COUGHING WITH STIMULATION AFTER RECENT FULL REVISION SURGERY ON (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN BUT THE ONLY FURTHER INFORMATION HE WOULD PROVIDE WAS THAT HE HAS STILL NOT SEEN THE PATIENT SINCE THE (B)(6) 2012 VISIT AND THAT HE DID NOT BELIEVE SHE HAD SEEN AN EAR, NOSE, AND THROAT (ENT) PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12043 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 202196

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention