BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3150381 · Received June 6, 2013

    Report

    Report Number
    1644487-2013-01701
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE ON SYSTEMS DIAGNOSTICS. THERE WAS NO REPORTED MANIPULATION OR TRAUMA AND THERE WERE NO ASSOCIATED ADVERSE EVENTS. THE GENERATOR WAS NOT DISABLED. X-RAYS WERE TAKEN BUT THEY WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. THE PATIENT DID NOT WANT TO DO ANYTHING AT THE TIME BUT HAS SINCE DECIDED THAT HE WOULD LIKE A REPLACEMENT. SURGERY IF LIKELY BUT HAS NOT OCCURRED TO DATE. 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

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE DEVICE WAS STILL PROGRAMMED ON. THE PATIENT STATED THAT HER SETTINGS WERE 150/125, BUT THE DEVICE WAS READING 75/100. THE MAGNET MODE STIMULATION FELT THE SAME. THE PATIENT STATED THAT SHE DID NOT REALIZE ¿THAT¿S WHY SHE HASN¿T FELT THE QUITE THE SAME.¿

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE ONLY COMPLICATION SHE WAS HAVING WAS LABORED BREATHING, ESPECIALLY WHEN SHE WORKED OUT THREE TO FOUR TIMES A WEEK.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED THAT THE PATIENT WAS GOING TO RECEIVE X-RAYS AFTER HIGH IMPEDANCE WAS OBSERVED. IT IS STATED THAT THE PATIENT HAD A MAMMOGRAM AND FELT THAT THE DEVICE WAS NOT OPERATING CORRECTLY. SHE WENT TO THE NEUROLOGIST AND RECEIVED WARNING FOR HIGH IMPEDANCE WHILE RUNNING THE DEVICE DIAGNOSTICS. IT WAS CLARIFIED THAT THE HIGH IMPEDANCE ISSUE FROM 2013 WAS NOT FIXED. THE PATIENT FEELS THAT THE VNS HAS BEEN WORKING GREAT AND WAS NOT OK HAVING SURGERY BACK IN 2013 TO FIX THE HIGH IMPEDANCE. THE PATIENT THOUGHT THE DEVICE WAS NOT WORKING PROPERLY DUE TO THE HIGH IMPEDANCE ISSUE. THE PATIENT HAS NOT HAD DEVICE REPLACEMENT TO DATE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A FULL REPLACEMENT ON (B)(6) 2015. IT WAS STATED THAT THE GENERATOR WILL BE RETURNED BUT THE LEAD WILL NOT. THE EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS ON 07/14/2015. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY BUT HAS NOT BEEN COMPLETED AND APPROVED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THE M103 GENERATOR WAS COMPLETED AND APPROVED ON (B)(4) 2015. VARIOUS ELECTRICAL LOADS WERE ATTACHED TO THE PULSE GENERATOR AND RESULTS OF DIAGNOSTIC TESTS DEMONSTRATE THAT ACCURATE RESISTANCE MEASUREMENTS WERE OBTAINED IN ALL INSTANCES. IN THE 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS . THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251445 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7763

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR