BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 302

    MDR report key: 881457 · Received July 17, 2007

    Report

    Report Number
    1644487-2007-01014
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 19, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PT X-RAYS ASSESSED BY MFR. RESULTS: ASSESSMENT OF X-RAYS REVEALED LEAD DISCONTINUITY. CONCLUSION: DEVICE MALFUNCTION IS SUSPECTED.

    Description of Event or Problem · 1

    REPORTER INDICATED, THAT PT PRESENTED FOR AN OFFICE VISIT WITH AN INCREASE IN SEIZURES. PT'S PRE-VNS BASELINE SEIZURE RATE IS UNK TO MFR AT THIS TIME. SYS DIAGNOSTICS AND NORMAL MODE DIAGNOSTICS TEST RUN DURING THE OFFICE VISIT YIELDED HIGH LEAD IMPEDANCE, INDICATING A POSSIBLE LEAD MALFUNCTION. MFR REVIEW OF X-RAYS REVEALED A LEAD DISCONTINUITY NEAR THE SECOND RIB IN THE THORACIC REGION. GOOD FAITH ATTEMPTS TO OBTAIN FURTHER INFO ARE CURRENTLY BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1547

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other