BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3163113 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01745
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 14, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE LEAD WAS NOT RETURNED TO MANUFACTURER FOR ANALYSIS. GENERATOR ANALYSIS WAS COMPLETED ON (B)(4) 2013. 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. THE BATTERY SHOWS A NON-IFI CONDITION. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE INCREASE IN SEIZURE WERE RELATED TO THE HIGH IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE. X-RAYS WERE TAKEN AND THERE WAS NOTHING OUT OF THE ORDINARY WAS OBSERVED ON THE X-RAY BY THE PHYSICIAN. X-RAYS WERE NOT BE PROVIDED TO THE MANUFACTURER FOR EVALUATION. DIAGNOSTICS WERE REPORTED TO BE WITHIN NORMAL LIMITS (B)(6) 2013. THERE WAS NO REPORTED OR POSSIBLE MANIPULATION OR TRAUMA. THE PATIENT HAD THEIR SETTING TURNED DOWN THAT DAY BUT NOT TURNED OFF. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT WAS IN AN ALTERCATION (B)(6) 2013 WHERE SHE WAS CHOKED AND HIT BUT DIAGNOSTICS WERE WITHIN NORMAL LIMITS AFTER THAT TIME. THE PATIENT WAS HAVING FREQUENT SEIZURES BUT THEY WERE NOT MORE SEVERE AND THE PATIENT WAS SICK AT THAT TIME. THE PATIENT HAD THEIR MEDICATIONS INCREASED AND THE PATIENT HAS HAD GOOD MEDICATION COMPLIANCE. THE PATIENT WAS BROUGHT BACK TO THE OFFICE AND HAD THEIR GENERATOR TURNED OFF. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT. IT WAS REPORTED THAT THERE WAS A LOT OF SCARRING IN THE AREA OF THE OLD LEAD ON THE NERVE. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263621 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 2736

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention