BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3140197 · Received May 31, 2013

    Report

    Report Number
    1644487-2013-01646
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES RECENTLY BUT WAS SCHEDULED FOR A GENERATOR REPLACEMENT AND THAT THE PATIENT¿S GENERATOR SHOWED DCDC=0 ON SYSTEM DIAGNOSTICS THEREFORE THE SURGEON WANTED TO GO AHEAD AND PROPHYLACTICALLY REPLACE THE LEAD DUE TO THE DCDC=0 SEEN AND BECAUSE THE LEAD HAD BEEN IMPLANTED FOR 14+ YEARS. THERE WAS NO INDICATION THAT THE PATIENT WAS REFERRED FOR REPLACEMENT DUE TO THE DCDC=0, JUST THAT THE SURGEON WANTED TO REPLACE THE LEAD IN CASE THERE WAS A FUTURE ISSUE WITH THE LEAD. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. A BLC WAS PERFORMED WHICH SHOWED 0.78 YEARS REMAINING UNTIL ERI=YES. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY AND HAS NOT YET BEEN COMPLETED. BEFORE REPLACEMENT THE PATIENT¿S SETTINGS WERE NOTED TO BE OUTPUT=1.25MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN/MAGNET OUTPUT=1.25MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC. THE PHYSICIAN DID NOT INDICATE WHAT THE RELATIONSHIP OF THE INCREASE IN SEIZURES WAS TO VNS BUT STATED THAT THEY FELT THE BATTERY HAD NOT BEEN WORKING FOR A PERIOD OF TIME BECAUSE OF THE INCREASE IN SEIZURES. THEY BELIEVED THE BATTERY WAS NEARING END OF SERVICE. IT WAS LATER REPORTED THAT THE BATTERY HAD BEEN IMPLANTED FOR 9.5 YEARS AND WAS STILL ABLE TO BE INTERROGATED BUT THE PHYSICIAN FELT THE BATTERY NEEDED TO BE REPLACED DUE TO THE LENGTH OF TIME IMPLANTED.

    Description of Event or Problem · 1

    ON (B)(4) 2013 PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN (B)(4), 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 DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND PRODUCT ANALYSIS FOUND NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION. PRODUCT ANALYSIS ON THE EXPLANTED LEAD WAS COMPLETED ON (B)(4) 2013. ABRADED OPENINGS WERE OBSERVED IN THE OUTER TUBING ONLY. SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENING AND THE ENDS OF THE RETURNED LEAD PORTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241664 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 22821C

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other