BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2500478 · Received March 22, 2012

    Report

    Report Number
    1644487-2012-00793
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 5, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE GENERATOR WAS CONFIRMED TO BE AT END OF SERVICE; AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF NORMAL, EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION, THE ELECTRICAL TEST RESULTS AND THE BENCH EVALUATION. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE MANUFACTURER'S CONSULTANT REPORTED THAT DURING THE PATIENT BATTERY REPLACEMENT SURGERY THAT DAY DUE TO END OF SERVICE (EOS), HIGH IMPEDANCE WAS SEEN DURING THE PRE-OPERATION DIAGNOSTICS. A SYSTEM DIAGNOSTICS SHOWED OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7/EOS=YES AND A NORMAL MODE DIAGNOSTICS SHOWED DCDC=2/EOS=YES. THE PATIENT'S SETTINGS WERE OUTPUT=0.75MA/FREQUENCY=30HZ/PULSE WIDTH=750USEC/ON TIME=60SEC/OFF TIME=10MIN. THE CONSULTANT THEN DECREASED THE PATIENT'S SETTINGS TO OUTPUT=0.75MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN AND THEN THE SYSTEM DIAGNOSTICS TEST SHOWED RESULTS WITHIN NORMAL LIMITS OF DCDC=2/EOS=YES. THE CONSULTANT STATED THAT SHE BELIEVES THE PATIENT'S HEAD WAS STRAIGHT IN THE FIRST SYSTEM DIAGNOSTICS TEST AND TURNED TO THE LEFT FOR THE SECOND DIAGNOSTICS TEST. DURING SURGERY THE SURGEON STATED THAT THE LEAD WAS A LITTLE KINKED CLOSE TO THE GENERATOR, BUT NO SIGN OF A LEAD FRACTURE. THE SURGEON UN-KINKED THE LEAD WHEN HE IMPLANTED THE NEW GENERATOR. AFTER THE SURGEON REPLACED THE GENERATOR HE PERFORMED SYSTEM DIAGNOSTICS INSIDE AND OUTSIDE THE GENERATOR POCKET AND RESULTS WERE WITHIN NORMAL LIMITS OF DCDC=2. THE LEADS WERE NOT REPLACED. THE CONSULTANT PERFORMED NORMAL MODE DIAGNOSTICS TESTS WITH THE PATIENT'S HEAD TURNED TO THE LEFT, RIGHT, AND STRAIGHT AND THE RESULTS WERE ALL WITHIN NORMAL LIMITS WITH A DCDC=0/EOS=NO. THE CONSULTANT ALSO PERFORMED SYSTEM DIAGNOSTICS TESTS WITH THE PATIENT'S HEAD TURNED TO THE LEFT AND STRAIGHT AND RESULTS WERE WITHIN NORMAL LIMITS OF DCDC=2/EOS. THE PATIENT WAS THEN PROGRAMMED TO OUTPUT=0.75MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN. THE CONSULTANT REPORTED THAT DURING SURGERY WAS THE FIRST TIME THAT THE HIGH IMPEDANCE WAS SEEN. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S HIGH IMPEDANCE. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2011 FOR PRODUCT ANALYSIS THAT HAS NOT YET BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 4813

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR