BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3102490 · Received May 9, 2013

    Report

    Report Number
    1644487-2013-01309
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    September 1, 2012
    Report Date
    April 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION THAT DAY DUE A ¿LEAD MALFUNCTION¿. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR PRODUCT ANALYSIS ON (B)(4)2013. PRODUCT ANALYSIS IS STILL UNDERWAY BUT HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED LEADS. VISUAL EXAMINATION OF THE CONNECTOR PIN SHOWED TWO SETSCREW INDENTATIONS AT THE END TIP SUGGESTING THAT THE LEAD CONNECTOR WAS NOT INSERTED COMPLETELY AT ONE POINT IN TIME. THE EXACT POINT IN TIME OF WHEN THIS OCCURRED IS UNKNOWN. BASED ON THE LOCATION OF ONE SET OF SETSCREW MARKS PRESENT ON THE CONNECTOR PIN AND SCRATCHES FROM THE CANTED SPRING OBSERVED ON THE CONNECTOR RING, IT IS BELIEVED THAT PROPER CONTACT BETWEEN THE PULSE GENERATOR ¿+¿ AND ¿¿¿ TERMINALS AND THE LEAD CONNECTOR RESPECTIVE CONTACT POINTS (CONNECTOR RING AND CONNECTOR PIN) EXISTED AT LEAST ONCE. THE LEAD CONNECTOR WAS INSERTED IN A REPRESENTATIVE PULSE GENERATOR HEADER AND NO ANOMALIES THAT COULD PREVENT PROPER INSERTION WERE IDENTIFIED. SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE BODY FLUIDS/BETADINE SOLUTION INSIDE THE INNER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS IDENTIFIED OTHER THAN THE CUT END OF THE RETURNED LEAD PORTION. PRODUCT ANALYSIS ON THE GENERATOR SHOWED AN OUTPUT PULSE DISABLED CONDITION DUE TO A PERCEIVED LOW BATTERY VOLTAGE; BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, INDICATING THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE EXPLANT, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. A RESET OF THE PULSE-DISABLED BIT IN THE GENERATOR MEMORY WAS PERFORMED TO ALLOW FOR AN OUTPUT TO ONCE AGAIN BE PROVIDED BY THE GENERATOR FOR SUBSEQUENT TESTING. THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THIS VNS PATIENT EXPERIENCING LIGHT-HEADEDNESS AND SHORTNESS OF BREATH AFTER A DOG FELL ON HER NECK. SETTINGS AND DIAGNOSTICS WERE ALL NORMAL. X-RAYS WERE TAKEN, BUT THE PHYSICIAN DID NOT SEE ANY ABNORMALITIES IN THE LEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT DIAGNOSTICS WERE RUN ON (B)(6) 2013, WITH THE PATIENT'S NECK IN SEVERAL DIFFERENT POSITIONS, AND EACH TIME, THE DIAGNOSTICS WERE ALL OK. THE PATIENT ALSO REPORTED PAIN IN THE NECK AREA DURING STIMULATION WHERE HER HEAD WAS UP. THE DEVICE WAS TEMPORARILY DISABLED, AND THE PAIN AND BREATHING PROBLEM IMPROVED. THERE WAS NO RECENT SETTINGS CHANGE. THE PATIENT FELL IN THE SHOWER IN DECEMBER AND THE SHORTNESS OF BREATH BEGAN AFTER THAT; HOWEVER, A DOG ALSO JUMPED ON THE PATIENT'S NECK AT IN (B)(6) 2012; HOWEVER, THE TIME OF THIS EVENT CANNOT BE CONFIRMED. THERE WAS NO REPORT OF DIZZINESS ON THIS DATE. THE PATIENT HAD NOT EXPERIENCED THIS SHORTNESS OF BREATH PRIOR TO THE INCIDENTS OF THE DOG JUMPING ON THE NECK/FALLING IN THE SHOWER. THE PATIENT WAS VISIBLY UNCOMFORTABLE WITH STIMULATION. THE PATIENT'S SETTINGS WERE PROVIDED. THE SETTINGS WERE TITRATED DOWN, AND THE DYSPNEA RECURRED. THE SETTINGS WERE FURTHER REDUCED TO BEARABLE SETTINGS. CT IMAGES WERE PROVIDED FOR REVIEW; HOWEVER, DUE TO IMAGE QUALITY, THEY COULD NOT BE ASSESSED. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203552 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7631

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other