BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2761290 · Received September 26, 2012

    Report

    Report Number
    1644487-2012-02445
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 15, 2012
    Report Date
    August 28, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, MODEL #, SERIAL #, LOT #, EXPIRATION DATE, MANUFACTURE DATE: CORRECTED DATA: PREVIOUSLY SUBMITTED MDR OMITTED PRODUCT INFORMATION. ADDITIONAL INFORMATION WAS PROVIDED WITH THE IMPLANTED PRODUCT INFORMATION. THIS REPORT IS BEING SENT TO CORRECT THIS INFORMATION. OPERATOR OF DEVICE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THE PATIENT WAS THE OPERATOR OF DEVICE; HOWEVER, AS THE PARALYSIS LIKELY RESULTED FROM SURGERY, THE HEATH PROFESSIONAL IS THE OPERATOR OF THE DEVICE. THIS REPORT IS BEING SENT TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012. THE PARALYSIS WAS NOT OCCURRING WITH STIMULATION. THE PATIENT WAS EVALUATED BY AN ENT AND WAS DIAGNOSED WITH AN IMMOBILE LEFT VOCAL CORD. THE PATIENT'S OUTPUT CURRENT WAS 0.25 MA. NO INTERVENTIONS WERE TAKEN, AND THE PATIENT DID NOT HAVE A HISTORY OF VOCAL CORD PARALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THIS VNS PATIENT WAS BELIEVED TO HAVE VOCAL CORD PARALYSIS. THE PATIENT HAD ALWAYS HAD A SOFTER VOICE, BUT HIS VOICE APPEARED TO BE EVEN SOFTER EVER SINCE IMPLANT. THE DEVICE WAS PROGRAMMED OFF AFTER IMPLANT ON 08/15/2012. THE PATIENT WAS SEEN ON (B)(6) 2012 AND THE DEVICE WAS PROGRAMMED ON. THE PATIENT WAS REFERRED BACK TO THE SURGEON. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202150

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other