BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3854359 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01432
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT INCLUDE THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    THE INITIAL MANUFACTURER REPORT INADVERTENTLY DID NOT INCLUDE THE OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN DIAGNOSED WITH VOCAL CORD PARALYSIS AND WAS REFERRED TO AN ENT. THE PHYSICIAN REPORTED THAT PATIENT EXPERIENCED VOICE ALTERATION TWO DAYS FOLLOWING SURGERY. X-RAYS WERE PERFORMED AND SHOWED SLIGHT ASYMMETRY. THE PATIENT WAS NOTED TO HAVE NORMAL SWALLOWING FUNCTION. THE PATIENT WAS REFERRED TO THE ENT. THE PATIENT WAS SEEN THE SAME DAY BY THE ENT. A SCOPE WAS PERFORMED WHICH FOUND LEFT VOCAL CORD PARALYSIS WHICH WAS ASSOCIATED WITH VNS SURGERY. IT WAS ALSO REPORTED THAT THE PATIENT WAS DIAGNOSED WITH TEMPORARY PALSY OF THE VAGAL NERVE RESULTING IN DYSPHONIA. IT WAS REPORTED THAT BOTH DIAGNOSES ARE BELIEVED TO BE ASSOCIATED WITH VNS IMPLANT SURGERY. THE PATIENT WAS PRESCRIBED STEROIDS AND WAS GIVEN A GOOD PROGNOSIS FOR RECOVERY. THE DEVICE WAS NOT PROGRAMMED ON. THE PHYSICIAN PLANS TO WAIT UNTIL THE PATIENT¿S VOICE RECOVERS. THE X-RAY REPORT NOTED THAT ASYMMETRY AND NOTED THE POSSIBILITY OF VOCAL CORD PARALYSIS ON THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332645 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 3815

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R