BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2864476 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03279
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 23, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED DURING SYSTEM DIAGNOSTICS PERFORMED ON (B)(6) 2012; OUTPUT=LOW/CURRENT DELIVERED=0MA/LEAD IMPEDANCE=HIGH/IMPEDANCE VALUE=10,000OHMS/IFI=NO. THE VNS WAS DISABLED DUE TO THE HIGH IMPEDANCE AND THE PATIENT WAS REFERRED FOR CHEST X-RAYS. THERE WAS NOT ANY TRAUMA OR MANIPULATION NOTED PRIOR TO THE HIGH IMPEDANCE. LATERAL NECK X-RAYS OF THE PATIENT WERE RECEIVED BY THE MANUFACTURER. THE GENERATOR WAS NOT DISPLAYED IN THE AVAILABLE VIEWS; THEREFORE NO ASSESSMENT COULD BE MADE ON WHETHER THE LEAD CONNECTOR PIN WAS FULLY INSERTED INTO THE GENERATOR. NO LEAD BREAKS OR SHARP ANGLES WERE OBSERVED IN THE PORTIONS OF THE LEAD THAT COULD BE CLEARLY ASSESSED. NO ASSESSMENT CAN BE MADE ON THE PARTS OF THE LEAD THAT WERE NOT VISIBLE. NO ASSESSMENT CAN BE DONE ON THE GENERATOR OR ITS PARTS AS THE DEVICE WAS NOT VISIBLE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS CONFIRMED THAT THIS VNS PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013. THE EXPLANTED DEVICES WERE RETURNED ON (B)(6) 2013. PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR SHOWED THAT A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 22.760% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS AND THE REPORTED HIGH IMPEDANCE ALLEGATION WAS CONFIRMED. DURING THE VISUAL ANALYSIS OF THE RETURNED 175MM PORTION THE (+) WHITE ELECTRODE QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 3MM FROM THE DISTAL END OF THE ANCHOR TETHER. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE WITH MECHANICAL DAMAGE AND RESIDUAL MATERIAL. THE ABRADED OPENINGS FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS OTHER THAN THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS. 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. 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 EXCEPT FOR THE SET OF SETSCREW MARKS FOUND NEAR THE END OF THE CONNECTOR PIN INDICATING THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE GENERATOR. THE ADDITIONAL 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.

    Description of Event or Problem · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR AND LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR