BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2981130 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00535
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING A SORE THROAT AND WAS HAVING PROBLEMS WITH HER VOICE WHICH MADE IT SO SHE COULD BARELY TALK FOLLOWING VNS IMPLANT SURGERY. THE PATIENT WAS DIAGNOSED WITH LEFT VOCAL CORD PARALYSIS BY AN ENT AFTER BEING SCOPED. THE PATIENT ALSO REPORTED HAVING TROUBLE BREATHING AND SWALLOWING AND FELT LIKE THERE WAS SOMETHING STUCK IN HER THROAT. THE FAMILY WAS TOLD THAT SHE HAD AN ADVERSE REACTION TO THE VNS SURGERY. THE PATIENT HAD HER GENERATOR DISABLED AND WAS GIVEN A STEROID WHICH DID NOT HELP. THE PATIENT HAS BEEN WEAK, TIRED AND NAUSEOUS AT TIMES SINCE THE SURGERY. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83448 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-30 201868

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability