BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 1190592 · Received October 6, 2008

    Report

    Report Number
    1644487-2008-02418
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTIONS NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD THEIR VNS GENERATOR REPLACED FOR END OF BATTERY LIFE AND THEIR LEAD REPLACED FOR LEAD BREAK. THE GENERATOR WAS RETURNED FOR ANALYSIS AND MET MFR SPECS. THE LEAD WAS RETURNED IN THREE PORTIONS. ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS AND THE REPORTED "FRACTURE OF LEAD" CONDITION WAS NOT VERIFIED. A LARGE PORTION OF THE LEAD ASSEMBLY BODY INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A COMPLETE EVAL COULD NOT BE PERFORMED ON THE ENTIRE LEAD PROD. ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED ON THE MARKED AND UNMARKED CONNECTOR BOOTS, CONNECTOR SILICONE TUBES AND OUTER SILICONE TUBING. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PINS AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. DEVICE FAILURE IS SUSPECTED ON THE PORTION OF THE LEAD NOT RETURNED. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADD'L DETAILS SURROUNDING THE REPORTED LEAD BREAK. THUS FAR NO FURTHER INFO HAS BEEN RECEIVED FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 13389C

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR