BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 6119283 · Received November 21, 2016

    Report

    Report Number
    1644487-2016-02702
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    August 1, 2016
    Report Date
    June 9, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S UNDERWENT FULL REVISION OF GENERATOR AND LEAD DUE TO HIGH IMPEDANCE. THE SUSPECT PRODUCT WAS RECEIVED FOR ANALYSIS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS VARIOUS ELECTRICAL LOADS WERE ATTACHED TO THE PULSE GENERATOR AND RESULTS OF DIAGNOSTIC TESTS DEMONSTRATE THAT ACCURATE RESISTANCE MEASUREMENTS WERE OBTAINED IN ALL INSTANCES. NO ANOMALIES WERE FOUND, THE INTERNAL DATA OF THE GENERATOR WAS REVIEWED AND FOUND THAT THE LAST 25% CHANGE IN IMPEDANCE OCCURRED ON (B)(6) 2017 FROM IMPEDANCE WITHIN NORMAL LIMITS (4281 OHMS) TO HIGH IMPEDANCE (5633 OHMS). THIS SUGGESTS AN INTERMITTENT LEAD FRACTURE WITH FLUCTUATING HIGH IMPEDANCE AS HIGH IMPEDANCE WAS DETECTED PRIOR TO (B)(6) 2017. PRODUCT ANALYSIS WAS COMPLETED ON THE LEAD. THE LEAD ASSEMBLY WAS RETURNED IN TWO PORTIONS. THE ELECTRODE ARRAY WAS NOT RETURNED, SO A COMPLETE ANALYSIS COULD NOT BE PERFORMED ON THE PRODUCT. SET-SCREW MARKS WERE OBSERVED ON THE LEAD PIN, WHICH INDICATES THAT AT ONE POINT IN TIME THERE WAS A GOOD ELECTRICAL AND MECHANICAL CONNECTION BETWEEN THE LEAD AND GENERATOR. THERE WERE MULTIPLE INSTANCES OF ABRADED OPENINGS OF THE INNER TUBING AND OF THE INNER AND OUTER TUBING. PORTIONS OF THE QUADFILAR COIL WERE EXPOSED. THERE WERE BODILY FLUIDS FOUND IN BOTH THE INNER AND OUTER TUBING THAT WERE ATTRIBUTED TO THESE OPENINGS. THE CAUSE OF THESE ABRADED OPENING WAS DETERMINED TO BE WEAR. A LEAD FRACTURE WAS NIT FOUND ON THE RETURNED PORTIONS. BEYOND THE ABRADED OPENINGS, THE CONDITION OF THE LEAD WAS TYPICAL OF THAT OF LEADS AFTER EXPLANT. NO FURTHER ANOMALIES FOUND. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED FINDING HIGH IMPEDANCE ON THE PATIENT'S GENERATOR DURING A VISIT ON (B)(6) 2016. THERE WAS NO KNOWN TRAUMA, BUT IT WAS STATED THAT TRAUMA WAS "CERTAINLY POSSIBLE GIVEN HIS CONDITION". NO REVISION SURGERY FOR THE HIGH IMPEDANCE HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770294 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 5986

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR