BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2211959 · Received August 15, 2011

    Report

    Report Number
    1644487-2011-01871
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2010 WHEN THE MANUFACTURER'S CONSULTANT REPORTED THAT THE HIGH IMPEDANCE WAS DISCOVERED RIGHT BEFORE HE WAS REFERRED FOR A FULL REVISION SURGERY, DATE NOT PROVIDED. THE PATIENT'S COUGHING RESOLVED AFTER SURGERY. THE CONSULTANT ALSO REPORTED THAT NO X-RAYS WERE TAKEN. THE CONSULTANT REPORTED THAT SHE WOULD RE-TRAIN THE SURGEON ON PROPER PIN INSERTION BUT THAT HE IS NOT GOING TO ADMIT THAT THE PATIENT HAD HIGH IMPEDANCE BACK ON (B)(6) 2010 AND THEY DIDN'T NOTICE IT. PRODUCT ANALYSIS OF THE EXPLANTED LEAD WAS COMPLETED ON (B)(6) 2011. THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO 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 DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTIONS OF THE DEVICE; HOWEVER, SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY COULD NOT BE MADE ON THAT PORTION OF THE LEAD. PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR WAS COMPLETED ON (B)(4) 2011. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Description of Event or Problem · 1

    ON JUL(B)(6) 2011, A VNS IMPLANTING SURGEON REPORTED THAT THE VNS PATIENT WAS HAVING A FULL REVISION SURGERY BECAUSE OF HIGH LEAD IMPEDANCE. THE PATIENT WAS EXPERIENCING SOME COUGHING WITH STIMULATION THEREFORE DIAGNOSTICS WERE RUN WHICH REVEALED HIGH LEAD IMPEDANCE. SPECIFIC DIAGNOSTIC RESULTS WERE NOT PROVIDED. THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND IT REVEALED THAT ON DATE OF IMPLANT, (B)(6) 2010, HIGH IMPEDANCE WAS DETECTED. THE SYSTEMS DIAGNOSTIC TEST PERFORMED THAT DAY SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE = HIGH/DCDC=7/ERI=NO. TWO MORE SYSTEM DIAGNOSTIC TESTS WERE RUN AFTERWARDS BUT BOTH WERE FAULTED. IT IS UNKNOWN IF THE PATIENT'S HIGH IMPEDANCE RESOLVED AFTER IMPLANT SURGERY OR HAS BEEN OCCURRING SINCE DATE OF IMPLANT. THE PATIENT WENT FOR FULL REVISION SURGERY ON (B)(6) 2011. ON (B)(6) 2011, THE EXPLANTED PRODUCT WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS THAT HAS NOT YET BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION ARE UNDERWAY. WHEN FURTHER INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-30 6980

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR