BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4213254 · Received October 30, 2014

    Report

    Report Number
    1644487-2014-02888
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR AND LEAD WAS COMPLETED. NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE PULSE GENERATOR. THE ABRADED OPENINGS AND SLICE MARK FOUND ON THE OUTER SILICONE TUBING OF THE RETURNED LEAD PORTION MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE OUTER SILICONE TUBING. THE SLICE MARK FOUND ON ONE OF THE INNER SILICONE TUBES MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS FOUND INSIDE THE INNER SILICONE TUBING. THERE WAS NO OBVIOUS PATH FOUND FOR THE FLUID INGRESS OBSERVED INSIDE THE SECOND INNER SILICONE TUBING. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTION OF THE DEVICE. NOTE THAT SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. FOLLOW-UP CLARIFIED THAT THE PATIENT¿S DEVICE WAS TESTED AND DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE. THE PATIENT PREVIOUSLY HAD A MOLE REMOVED FROM HER BACK USING DIATHERMY AND IT WAS BELIEVED THAT THE PROCEDURE HAD DAMAGED THE PATIENT¿S DEVICE. DURING THE REPLACEMENT PROCEDURE ON (B)(6) 2014, THE REPLACEMENT GENERATOR WAS TESTED WITH THE EXISTING LEAD AND SYSTEM DIAGNOSTICS STILL SHOWED HIGH IMPEDANCE. THE PATIENT¿S LEAD WAS THEN REPLACED AND THE HIGH IMPEDANCE CONDITION WAS RESOLVED. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697509 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200788

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR