BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2834216 · Received November 15, 2012

    Report

    Report Number
    1644487-2012-03029
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT THAT WAS INITIALLY IMPLANTED WITH THE VNS ON (B)(6) 2012 WAS EXPERIENCING A LEAD-PULLING SENSATION, PAIN IN THE NECK WITH VNS SYSTEMS DIAGNOSTICS TESTING, HOARSENESS, AND DYSPHAGIA. THE LEAD IS VISIBLE BENEATH THE SKIN. THE GENERATOR WAS NOT ENABLED, AND THE PATIENT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS. X-RAYS WERE RECEIVED BY THE MANUFACTURER WHICH ILLUSTRATED PROFOUND TWIDDLING OF THE LEAD AT THE GENERATOR SITE, INDICATIVE OF PATIENT MANIPULATION OF THE LEAD. ON (B)(6) 2012, THE PATIENT WAS SEEN BY AN ENT PHYSICIAN AND DIAGNOSED WITH LEFT VOCAL CORD PARESIS. ON (B)(6) 2012, THE PATIENT HAD VNS LEAD REPLACEMENT SURGERY PERFORMED. ATTEMPTS FOR RETURN OF THE EXPLANTED VNS LEAD ARE IN PROGRESS.

    Description of Event or Problem · 1

    THE COMPLETE EXPLANTED LEAD ASSEMBLY WAS RETURNED IN TWO PIECES FOR ANALYSIS ON (B)(6) 2012.THE CONDITION OF THE RETURNED THE LEAD, IN GENERAL, IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING MANIPULATION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.

    Description of Event or Problem · 1

    X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER.IT CANNOT BE DETERMINED FROM THE IMAGE IF THE LEAD CONNECTOR PIN IS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK, OR THE LEAD WIRES ARE INTACT AT THE CONNECTOR PIN. THE ENTIRE LEAD IS VISIBLE AND CAN BE SEEN TIGHTLY WOUND UP NEAR THE GENERATOR, WHICH POINTS AT PATIENT TWIDDLING. NO ACUTE ANGLES OR OBVIOUS LEAD BREAK COULD BE IDENTIFIED IN THE VISIBLE PORTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 202021

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention