BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2705439 · Received August 20, 2012

    Report

    Report Number
    1644487-2012-02063
    Event Type
    Malfunction
    Date Received
    August 20, 2012
    Date of Event
    July 21, 2012
    Report Date
    July 26, 2012
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED BOTH LEAD AND GENERATOR MET SPECIFICATIONS PRIOR TO DISTRIBUTION. BRAND NAME; COMMON DEVICE NAME; MODEL #, SERIAL #, LOT #, EXPIRATION DATE; DEVICE MANUFACTURE DATE; CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED WHICH CHANGES THE PRODUCT FROM WHAT WAS INITIALLY REPORTED ON INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT 5 DAYS AGO THE PATIENT STOPPED BEING ABLE TO FEEL NORMAL MODE STIMULATION. THE PATIENT HAS ALSO BEEN EXPERIENCING AN INTERMITTENT PAIN IN THE NECK OVER THE PAST 5 DAYS. THE PATIENT DENIED ANY FALLS OR TRAUMA TO THE NECK/CHEST. THE PATIENT SAW HER PHYSICIAN AND THE PHYSICIAN REPORTED THAT A SYSTEM DIAGNOSTICS TEST SHOWED HIGH IMPEDANCE WITH AN IMPEDANCE VALUE 10,000OHMS. THE PHYSICIAN DISABLED THE DEVICE AND REFERRED THAT PATIENT FOR SURGERY. IT WAS UNCLEAR IF X-RAYS WERE GOING TO BE TAKEN BUT THEY WOULD NOT BE SENT TO THE MANUFACTURER FOR REVIEW. THE PHYSICIAN LATER REPORTED THAT HE BELIEVES THE PAIN IS RELATED TO VNS AND IS LIKELY DUE TO A LEAK OF STIMULATION. THE PHYSICIAN FURTHER INDICATED THAT THE PATIENT IS 6 MONTHS PREGNANT. CLINIC NOTES WERE RECEIVED FROM THE (B)(6) 2012 CLINIC VISIT WHICH REPORTED THAT THE PATIENT HAS A SHARP PAIN IN THE NERVE THAT STARTED THE NIGHT BEFORE AND WAS CONSTANT. THERE IS A POSSIBLE LEAD FRACTURE. THE DEVICE WAS DISABLED DUE TO THE PAIN. THE PATIENT'S SETTINGS PRIOR TO THIS WAS OUTPUT=0.5MA/FREQUENCY=25HZ/PULSE WIDTH=130USEC/ON TIME=30SEC/OFF TIME=3MIN/MAGNET OUTPUT=1MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC. IT WAS ALSO REPORTED IN CLINIC NOTES DATED (B)(6) 2012 THAT THE PATIENT HAS DEPRESSION. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE EXPLANTED GENERATOR WOULD BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. IT WAS STATED THAT THE GENERATOR HAD BEEN REPLACED DUE HIGH IMPEDANCE AND THAT THE LEAD WAS NOT REPLACED. THE EXPLANTED GENERATOR HOWEVER, HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE VNS PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT HAD PAIN AROUND THE GENERATOR AND LEFT NECK AND THE DEVICE WAS TURNED OFF DUE TO THE PAIN. THE PATIENT HAD SURGERY ON (B)(6) 2013 AND ONLY THE GENERATOR WAS REPLACED. IT WAS REPORTED THAT THE GENERATOR WAS FIRST REPLACED AND THEN AN IMPEDANCE VALUE OF 3960OHMS WAS OBSERVED, WHICH IS WITHIN NORMAL LIMITS, AND THEREFORE THE SURGEON DID NOT WANT TO REPLACE THE LEADS. THE EXPLANTED GENERATOR COULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ACCORDING TO THE HOSPITAL. REVIEW OF MANUFACTURING RECORDS CONFIRMED BOTH THE GENERATOR AND LEAD MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. NO OBSTRUCTIONS WERE OBSERVED IN THE HEADER LEAD CAVITY OR CONNECTOR BLOCKS. IN ADDITION, THE IN-LINE CAVITY GO GAUGE TEST PASSED. A BENCH LEAD INSERTED COMPLETELY PASSED THE NEGATIVE CONNECTOR BLOCK AND WAS SECURED WITH THE RETURNED SETSCREW. 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. THE BATTERY, 2.977 VOLTS, 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

    ON (B)(4) 2013 THE PATIENT'S EXPLANTED GENERATOR WAS RECEIVED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. THE MANUFACTURER'S CONSULTANT REPORTED THAT THE PATIENT CONTINUES TO HAVE PAINFUL STIMULATION IN THE NECK DESPITE GENERATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3137

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention