BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2950752 · Received February 8, 2013

    Report

    Report Number
    1644487-2013-00346
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S INCREASE IN SEIZURES IS A SERIOUS INJURY/ADVERSE EVENT. THE INCREASE IN SEIZURES ARE RELATED TO THE HIGH IMPEDANCE. DEVICE FAILURE IS SUSPECTED AND MAY HAVE CONTRIBUTED TO THE PATIENT'S INCREASED SEIZURES.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON 09/30/2013. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, SHOWING SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATING 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. HOWEVER, FURTHER REVIEW OF THE RAM AND FLASH DATA, DOWNLOADED FROM THE GENERATOR, SHOWS HIGH IMPEDANCE HAD OCCURRED DURING DEVICE IMPLANT. THE DATA FROM THE DECODER SPREAD SHEET SHOWS A CHANGE IN IMPEDANCE, THE ESTIMATED OCCURRENCE WAS ON (B)(6) 2013, FROM 12586 OHMS (PRIOR TO EXPLANT) TO 3993 OHMS (EXPLANT DATE (B)(6) 2013). THE COMBINATION OF A HIGH IMPEDANCE VALUE AND OUTPUT CURRENT (2.00MA VNS DATABASE) SETTING REQUIRED A ¿VBOOST¿ COMPLIANCE VOLTAGE THAT EXCEED THE MAXIMUM COMPLIANCE VOLTAGE CAPABILITY FOR THE DEVICE (>10.5 V). REVIEW OF THE ELECTRICAL CHARACTERIZATION REPORT STATES THAT THE LONGEVITY ESTIMATES ARE NOT GUARANTEED AT COMPLIANCE VOLTAGES GREATER THAN 10.5V. THIS CONDITION CONTRIBUTES TO THE DISPARITY BETWEEN THE NEAR NEOS CONDITION AND THE % BATTERY CAPACITY THAT HAS BEEN CONSUMED, BASED ON THE DEVICE¿S INTERNAL EOS PROJECTION SYSTEM. THIS IS A KNOWN, PROGRAMMED EVENT. OTHER THAN THE NOTED CONDITION, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE GENERATOR AND LEAD WERE DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS. AN IMPLANT CARD WAS RECEIVED INDICATING THAT BOTH THE LEAD AND GENERATOR WERE EXPLANTED ON (B)(6) 2013 DUE TO "HIGH LEAD IMPEDANCE, BATTERY DEPLETION AND ABNORMAL DIAGNOSTICS". THE IMPLANT CARD LISTED THE INDICATION FOR USE AS "EPILEPSY AND INCREASED SEIZURE FREQUENCY FROM BASELINE".

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE DIAGNOSTIC TESTING RESULTED IN HIGH IMPEDANCE. IT WAS REPORTED THAT THE DEVICE WAS PROGRAMMED OFF TO PREVENT DAMAGE TO THE PATIENT'S VAGAL NERVE. IT WAS ALSO REPORTED THAT THE PATIENT HAD PROJECTILE VOMITING THREE TIMES A DAY AND THAT THE PATIENT WAS SCHEDULED FOR SURGERY. THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2013. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR WAS NOT DISCARDED AS REPORTED TO THE MANUFACTURER PREVIOUSLY. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE NEUROLOGIST'S NOTES INDICATED THAT THE PATIENT HAD EXPERIENCED AN INCREASE IN SEIZURES SINCE CHRISTMAS; HOWEVER, IT WAS NOT NOTED WHETHER THE INCREASE WAS ABOVE THE PATIENT'S PRE-VNS BASELINE OR WHAT THE PHYSICIAN'S ATTRIBUTED THE INCREASE TO. THE NOTES INDICATED THAT THE GENERATOR WAS AT IFI = YES AND THERE WAS HIGH IMPEDANCE >1000 OHMS AND THAT IS WHEN THE PATIENT WAS REFERRED FOR SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54526 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 011314

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention