BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4161859 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02621
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE (IMPEDANCE VALUE >= 10,000 OHMS). CLINIC NOTES WERE RECEIVED INDICATING THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURE FREQUENCY AND DURATION FOR THE PAST THREE WEEKS PRIOR TO THE OFFICE VISIT ON (B)(6) 2014. THE PATIENT NORMALLY HAD 5-6 BRIEF SEIZURES PER DAY OR PER WEEK; HOWEVER, THE PATIENT WAS HAVING SEIZURES THAT LASTED UP TO FIVE MINUTES AND TOOK LONGER TO BREAK DOWN. IT WAS NOTED THAT THE PATIENT GAINED THE BEST SEIZURE CONTROL WITH VNS. THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO HIGH IMPEDANCE. THE EXPLANTED DEVICES HAVE NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. VARIOUS ELECTRICAL LOADS WERE ATTACHED TO THE GENERATOR AND RESULTS OF DIAGNOSTIC TESTS DEMONSTRATE THAT ACCURATE RESISTANCE MEASUREMENTS WERE OBTAINED IN ALL INSTANCES. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. ANALYSIS OF THE RETURNED LEAD PORTION CONFIRMED DISCONTINUITY OF THE NEGATIVE QUADFILAR COIL IN THE ELECTRODE REGION. THE ABRADED OPENINGS FOUND ON THE OUTER SILICONE TUBING MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE OUTER SILICONE TUBING. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639869 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200772

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention