BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 4552258 · Received February 26, 2015

    Report

    Report Number
    1644487-2015-03989
    Event Type
    Injury
    Date Received
    February 26, 2015
    Date of Event
    August 20, 2014
    Report Date
    February 4, 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
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN (B)(6) 2014 THAT THE PATIENT WAS BEING REFERRED TO AN ENT TO ASSESS VOICE HOARSENESS. THE FREQUENCY OF THE VOICE HAD DROPPED THAT DAY. DIAGNOSTICS WERE REPORTEDLY WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT HAD PRE-EXISTING HOARSENESS. THE TREATING PHYSICIAN WAS UNSURE IF THERE HAS BEEN ANY CHANGE SINCE VNS AND THE RELATIONSHIP TO VNS. HOWEVER, THE PHYSICIAN WANTED TO MAKE SURE IT WAS NOT RELATED. IT WAS REPORTED ON (B)(6) 2015 THAT THE PATIENT SAW THE ENT AND HIS NOTES MENTION VOCAL CORD PARALYSIS. THE ENT ADDED STITCHES, AND THE PATIENT IS REPORTEDLY DOING BETTER. GOOD FAITH ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE ENT REPORTED THAT THE PARALYSIS WAS ISOLATED TO THE LEFT VOCAL CORD AND OCCURRED AS A RESULT OF IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135936 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 3902

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention