BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3133821 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01617
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    June 6, 2012
    Report Date
    May 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SUPPLEMENTAL 2 MDR INCORRECTLY REPORTED THAT MODEL 102R, SERIAL NUMBER (B)(4) GENERATOR WAS RETURNED; HOWEVER, THIS WAS FOUND TO BE AN ERROR. THE MODEL 102R, SERIAL NUMBER (B)(4) GENERATOR WAS NOT RETURNED. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HIGH LEAD IMPEDANCE WAS OBTAINED FOR A PATIENT AT AN OFFICE VISIT WITH VNS DIAGNOSTICS TESTING ON (B)(6) 2013. THE PATIENT HAD NO TRAUMA AND DID NOT MANIPULATE THE VNS. THE LAST ACCEPTABLE DIAGNOSTICS WERE ON (B)(6) 2012, BUT WERE NOT SPECIFIED. THE VNS WAS DISABLED AND THE PATIENT WAS REFERRED FOR SURGERY. PRIOR TO THE SURGERY ON (B)(6) 2013, VNS DIAGNOSTICS INDICATED NORMAL DEVICE FUNCTION. A NEW GENERATOR WAS CONNECTED TO THE RESIDENT LEAD AND NORMAL IMPEDANCE WAS OBTAINED, SO THE LEAD WAS NOT REPLACED. WHEN THE PATIENT PRESENTED AT AN OFFICE VISIT LATER ON (B)(6) 2013, HIGH LEAD IMPEDANCE WAS OBTAINED. X-RAYS AND POSSIBLE REPLACEMENT OF THE LEAD AND GENERATOR IS PLANNED. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    THE EXPLANTED VNS LEAD, MODEL 102R, SN (B)(4) GENERATOR, AND UNUSED NEW MODEL 104, SN (B)(4) GENERATOR WERE RETURNED AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    THE MODEL 102R, SERIAL NUMBER (B)(4) GENERATOR WAS NOT RETURNED TO THE MANUFACTURER AS PREVIOUSLY REPORTED. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS AND A LEAD FRACTURE WAS CONFIRMED.. NOTE THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED 22 MM PORTION THREE BROKEN COIL STRANDS WERE OBSERVED ON QUADFILAR COIL 1 AND QUADFILAR COIL 2 APPEARED TO BE BROKEN NEAR THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON BOTH OF THE COILS AND IDENTIFIED THE AREAS AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE AND NO PITTING. IT IS UNKNOWN IF THE BREAKS OCCURRED WHILE STIMULATION WAS PRESENT DUE TO THE ABSENCE OF METAL PITTING ON THE BROKEN COIL WIRE SURFACES. THE ABRADED OPEN / CUT AND CUT OUT HOLE 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. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. EDS (ENERGY DISPERSION SPECTROSCOPY ¿ PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING SILICON, PHOSPHORUS AND CALCIUM. REFER TO ATTACHED EDS SHEET FOR ADDITIONAL INFORMATION. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITIES, 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 PINS 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. NOTE THAT A BREAK OF A FEW STRANDS WOULD STILL ALLOW CURRENT FLOW THROUGH THAT PORTION OF THE LEAD. THIS OBSERVATION IS SUPPORTED BY RESULTS OF ELECTRICAL MEASUREMENTS WHICH VERIFIED CONTINUITY BETWEEN THE ENDS OF THIS LEAD SECTION. A SUMMARY OF THE RESULTS CAN BE FOUND ON FIGURE 14. 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 ALLEGATIONS OF ¿EXPLANTED / DUE TO LEAD BREAK / HIGH IMPEDANCE¿. NOTE THAT SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. THE MODEL 104, SERIAL NUMBER (B)(4) GENERATOR WAS RETURNED AND PRODUCT ANALYSIS WAS PERFORMED. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PRODUCT ANALYSIS LAB. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT X-RAYS DID NOT SHOW ANY LEAD BREAKS, AND HIGH LEAD IMPEDANCE IS STILL OCCURRING. THE X-RAYS WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. THE REPORTER WAS ADVISED TO DISABLE THE VNS DUE TO THE HIGH IMPEDANCE. THE PATIENT LATER HAD VNS LEAD AND GENERATOR REPLACEMENT SURGERY PERFORMED ON (B)(6) 2013. DIAGNOSTICS WITH THE NEW GENERATOR AND LEAD WERE WITHIN NORMAL LIMITS.ATTEMPTS FOR RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237116 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 39307C

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR