BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4201473 · Received October 27, 2014

    Report

    Report Number
    1644487-2014-02830
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 30, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: THE SUPPLEMENTAL REPORT #1 INADVERTENTLY DID NOT REPORT THIS DATA. DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE SUPPLEMENTAL REPORT #1 INADVERTENTLY DID NOT REPORT THIS DATA.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PER INTERNAL DATA OBTAINED THROUGH PRODUCT ANALYSIS FROM THE EXPLANTED GENERATOR REVEALED THAT THERE WAS A CHANGE IN IMPEDANCE READING FROM 2209 OHMS TO 10000 OHMS ON APPROXIMATELY (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE. THE PATIENT HAD THEIR GENERATOR TURNED OFF AND WAS SCHEDULE FOR SURGERY. THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT AND THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED, BUT HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.941 VOLTS AS MEASURED SHOWS AN IFI=NO CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 57.124% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. NOTE THAT A PORTION OF THE (-) GREEN ELECTRODE QUADFILAR COIL WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED 455MM PORTION THE END OF THE (-) CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN AT THE DISTAL END OF THE ANCHOR TETHER. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS BEING MECHANICALLY DAMAGED WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE WITH PITTING. PITTING WAS OBSERVED ON THE COIL SURFACE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY WHICH MAY INCLUDE: MATERIAL FRACTURE, ROUGH OR PITTED SURFACE, THINNED MATERIAL THICKNESS, ELECTRO-ETCHING OR MATERIAL DISSOLUTION. THE ABRADED OPENING AND SLICE MARK 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 PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTIONS OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED ALLEGATION OF 'FRACTURE OF 'HIGH IMPEDANCE' NOTE THAT SINCE A PORTION OF THE (-) GREEN ELECTRODE QUADFILAR COIL WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684864 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200991

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR