BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2192435 · Received July 27, 2011

    Report

    Report Number
    1644487-2011-01707
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ENT SURGEON THAT A VNS PT WAS HAVING DYSPNEA, PARESIS, AND VOICE ALTERATION. THE VOICE ALTERATION AND PARESIS WERE OCCURRING WITH VNS STIMULATION AND PT'S VOCAL CORDS WOULD GET IMMOBILIZED. HOWEVER, HER VOCAL CORDS WOULD RETURN TO NORMAL FUNCTION AFTER VNS STIMULATION STOPPED. ADDITIONALLY, THE PHYSICIAN STATED THAT AT TIMES, THE PT'S VOCAL CORDS GET CONSTRICTED SO SEVERELY DURING THE ON TIMES THAT IT CUTS OFF HER BREATHING. THIS CONDITION GETS WORSE DURING EXERCISE FOR PT. PT HAS BEEN HAVING A GREAT SEIZURE CONTROL WITH VNS THERAPY AND WOULD LIKE TO KEEP THE VNS TURNED ON. THE PT'S GENERATOR'S DIAGNOSTICS WERE WITHIN NORMAL LIMITS ON (B)(4) 2011. DURING (B)(4) 2011, PT COMPLAINED THAT HER THROAT WAS BOTHERING HER BUT DID NOT WANT THE SETTING LOWERED. DURING THE NEXT APPOINTMENT ON (B)(4) 2011, PT'S SETTINGS, PULSE WIDTH AND FREQUENCY WERE LOWERED AND PT'S PAIN WAS RESOLVED. MFR RECEIVED AND REVIEWED THE X-RAYS. THE ALIGNMENT OF THE POSITIVE AND NEGATIVE ELECTRODES APPEARED TO BE NORMAL. THE LEAD WAS ROUTED TOWARDS THE GENERATOR. THE GENERATOR WAS PLACED ON THE LEFT CHEST AND A SMALL AMOUNT OF LEAD WAS PLACED BEHIND THE GENERATOR. THE CONNECTOR PIN COULD NOT BE ASSESSED SINCE THE GENERATOR WAS ONLY PARTIALLY VISIBLE IN THE X-RAY IMAGES. HOWEVER, THE FILTER FEED-THRU WIRES APPEARED TO BE INTACT. BASED ON THE X-RAY IMAGES RECEIVED, NO OBVIOUS ANOMALIES COULD BE IDENTIFIED IN VISUALIZED PORTION OF THE PT'S VNS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 204536

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention