BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 4765594 · Received May 12, 2015

    Report

    Report Number
    1644487-2015-04672
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    October 17, 2014
    Report Date
    April 16, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT; CORRECTED DATA: THE INITIAL MDR INADVERTENTLY DID NOT INDICATE THE OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2015 NOTE THAT THE PATIENT HAS HAD SOME HOARSENESS SINCE THE PLACEMENT OF THE VNS. IT WAS NOTED THAT A STROBE SHOWS VOCAL CORD PARALYSIS. IT WAS NOTED THAT INDIRECT EXAMINATION OF THE LARYNX SHOWED LEFT VOCAL CORD PARALYSIS IN A PARAMEDIAN POSITION. IT WAS REPORTED THAT THE ENT SURGEON IS CONSIDERING SURGERY FOR THE VOCAL CORD PARALYSIS. IT WAS REPORTED THAT THE ENT SURGEON BELIEVES THAT THE IMPLANT SURGERY IS THE DIRECT CAUSE OF THE VOCAL CORD PARALYSIS. IT WAS REPORTED THAT THE PATIENT WILL UNDERGO VOCAL CORD MEDICALIZATION SURGERY TO IMPROVE THE HOARSE VOICE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT VOCAL CORD MEDIALIZATION SURGERY ON (B)(6) 2015. THE PATIENT¿S DEVICE WAS TESTED AND SHOWED NORMAL DEVICE FUNCTION. FOLLOW-UP WITH THE ENT SURGEON REVEALED THAT THE PATIENT¿S VOICE HAD IMPROVED, BUT THE SURGEON BELIEVED THE PATIENT¿S NERVE AND VOCAL CORD WERE NEVER GOING TO BE BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309369 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202934

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention