BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 5242672 · Received November 23, 2015

    Report

    Report Number
    1644487-2015-06532
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    July 13, 2015
    Report Date
    November 2, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: INADVERTENTLY DID NOT INCLUDE THE SUSPECT DEVICE UDI ON THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT REPORTED THAT HER VOICE ALTERATION, WHICH SHE STATED IS NOT RELATED TO VNS STIMULATION, HAS PROGRESSED SINCE SURGERY TO THE POINT WHERE SHE BELIEVES SHE HAS, AT A MINIMUM, PARTIAL VOCAL CORD PARALYSIS. THE PATIENT NOTED SHE ALSO HAS SEVERE PAIN WHEN TRYING TO SPEAK. IT WAS PREVIOUSLY REPORTED ON (B)(6) 2015 THAT THE PATIENT EXPERIENCED VOICE ALTERATION AND DYSPNEA FOLLOWING IMPLANT SURGERY ON (B)(6) 2015. THE PATIENT WENT TO THE EMERGENCY ROOM AND RECEIVED ANTI-INFLAMMATORIES AND ALBUTEROL. THE ISSUES RESOLVED, AND IT IS PLANNED TO TURN ON THE VNS ON (B)(6) 2015. THE PATIENT LATER REPORTED THAT SHE STILL HAS NOT YET GOTTEN HER VOICE BACK AND SINCE RECEIVING VNS SHE HAS BEEN EXPERIENCING NAUSEA WHILE EATING AND IT FEELS LIKE THERE IS "AIR IN HER CHEST". GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773958 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 4094

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR