BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2872686 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03336
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 21, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION CAUSED EVENT BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES. CORRECTED DATA UPDATED TESTING RESULTS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THEIR EXPLANTED GENERATOR. THE BATTERY WAS PARTIALLY DEPLETED AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY CONSUMPTION BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. 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. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. THE LEAD ANALYSIS WAS COMPLETED. A SECTION OF THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS IN TWO PIECES. THE LEAD'S ELECTRODES WERE NOT RETURNED FOR EVALUATION. THE OUTER SILICONE TUBING HAS ABRASIONS AT MULTIPLE LOCATIONS. SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN, PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED AT LEAST ONCE. ABRADED OPENINGS WERE IDENTIFIED IN THE OUTER AND THE INNER SILICONE TUBING OF THE LEAD COILS RESULTING IN PORTION OF THE LEAD COILS EXPOSED. ALSO, APPEARS WEAR WAS IDENTIFIED ON THE LEAD COILS AT THE LEAD BODY. VISUAL ANALYSIS OF THE POSITIVE COIL AT THE LOCATION OF AN OPAQUE APPEARANCE, SHOWS THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED ON THE COIL SURFACE. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE END OF THE RETURNED LEAD PORTIONS. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    NO PREOPERATIVE X-RAYS WERE TAKEN PRIOR TO SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT A VNS PATIENT'S DEVICE WAS SHOWING UPON INTERROGATION TO BE NEARING END OF BATTERY LIFE. THE PATIENT HAD STARTED TO HAVE AN INCREASE IN SEIZURES, WHICH THE PHYSICIAN ATTRIBUTES TO THE EOS CONDITION. THEIR MAGNET SETTINGS WERE RAISED AS THEIR MAGNET WAS NOT ABORTING THEIR SEIZURES. IT NOW WORKS. IN (B)(6) 2012 VISIT HE HAD EXPERIENCED AN INCREASE IN SEIZURES FOLLOWING AN INPATIENT ADMITTANCE TO COLLEGE HILL FOR ACTING OUT BEHAVIORS. THE PATIENT HAS AUTISM. HIS SEIZURES WERE OCCURRING 1-2X PER WEEK AND CONTINUED TO BE NOCTURNAL IN NATURE. THEY WERE NON RESPONSIVE TO THE VNS MAGNET - FOLLOWING CURRENT CHANGE THIS RESOLVED. HIS SEIZURES ARE UNDER SUBOPTIMAL CONTROL ON BOTH ZONISAMIDE, LAMICTAL, AND VNS. HIS CURRENT NOCTURNAL EVENTS ARE TONIC EXTENSION IN SEMIOLOGY LASTING 10-15 MIN-ABORTED WITH NASAL VERSED. WHILE THEY INITIALLY INCREASED IN FREQUENCY WITH THE ADDITION OF AN ATYPICAL ANTIPSYCHOTIC WITH ADJUSTMENT OF HIS LAMICTAL THEY DECREASED WITH IMPROVEMENT IN BEHAVIORS AND SLEEP UNTIL RECENTLY WHEN THEY INCREASED FROM 1-2/WEEK TO NIGHTLY. FOLLOWING VNS INTERROGATION IT WAS NOTED THAT HIS BATTERY WAS AT END OF SERVICE. THE PATIENT WENT TO SURGERY (B)(6) AND A FULL REVISION WAS PERFORMED. IT WAS NOTED IN THE OR THAT THEIR LEAD BODY WAS FRAYED BELOW THE GENERATOR IN THE POCKET. THEIR EXPLANTED PRODUCTS HAVE BEEN RETURNED FOR ANALYSIS AND ARE PENDING COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011296

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR