BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3172726 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01799
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAS HIGH LEAD IMPEDANCE DURING A DIAGNOSTICS TEST; OUTPUT=LIMIT/LEAD IMPEDANCE=HIGH/DCDC=7. THE PATIENT¿S SETTINGS WERE NOTED TO BE OUTPUT=2.5MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=21SEC/OFF TIME=1.1MIN/MAGNET OUTPUT=2.75MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC. IT WAS REPORTED THAT DIAGNOSTICS HAD NOT BEEN PERFORMED AT THE PATIENT¿S LAST VISIT; IT WASN¿T UNTIL THE SURGEON PERFORMED DIAGNOSTICS DURING THE CONSULT VISIT THAT THE HIGH IMPEDANCE WAS OBSERVED. NO X-RAYS WERE BEING PERFORMED. IT WAS STATED THAT THE SURGEON WAS GOING TO DO A FULL REVISION. THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. IT WAS STATED THAT THE EXPLANTED PRODUCTS CANNOT BE RETURNED FOR PRODUCT ANALYSIS AS IT IS THE HOSPITAL¿S POLICY TO DESTROY ALL EXPLANTED DEVICES. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273026 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1651

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR