BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 4482287 · Received February 4, 2015

    Report

    Report Number
    1644487-2015-03724
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    December 29, 2014
    Report Date
    January 7, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY PROVIDED AN INCORRECT YEAR FOR THIS FIELD. THE YEAR IS LISTED AS 03/03/3015 WHEN THE ACTUAL DATE IS 03/03/2015. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT THE PATIENT HAD VOCAL CORD PARALYSIS FOLLOWING VNS REPLACEMENT SURGERY ON (B)(6) 2014. HE WAS GIVEN A DOSE PACK TO TAKE AND FOLLOW UP ON (B)(6) 2015. THE LIKELY CAUSE WAS THE SURGERY.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS ATTAINED THAT THE ONLY THE PATIENTS LEFT VOCAL CORD WAS AFFECTED, AND IT HAS SINCE RESOLVED. THEIR DOCTOR BELIEVES THE CONDITION WAS A RESULT OF MANIPULATION DURING SURGERY. THEIR DEVICE HAS SINCE BEEN ACTIVATED AND IS PERFORMING AS INTENDED WITH NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80128 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202934

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other