BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4213126 · Received October 30, 2014

    Report

    Report Number
    1644487-2014-02887
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DEVICE RECORDS WERE REVIEWED. REVIEW OF THE LEAD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY REPORTED THAT AFTER THE GENERATOR WAS REPLACED, LEAD IMPEDANCE WAS OKAY. HOWEVER, LEAD IMPEDANCE WAS NOT OKAY UNTIL AFTER THE LEAD WAS ALSO REPLACED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT. LATER, IT WAS REPORTED THAT THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO HIGH LEAD IMPEDANCE. THE IMPLANT CARD REPORTED THAT THE REASON FOR REPLACEMENT WAS HIGH LEAD IMPEDANCE AND UNABLE TO INTERROGATE DUE TO BATTERY DEPLETION. PRE-OPERATIVE DIAGNOSTICS WERE UNABLE TO BE PERFORMED DUE TO DEPLETED GENERATOR BATTERY. IT WAS REPORTED THAT WHEN THE SURGEON REMOVED THE LEAD FROM THE EXPLANTED GENERATOR, HIGH LEAD IMPEDANCE WAS OBSERVED WITH THE NEW GENERATOR. AFTER THE GENERATOR WAS ALSO REPLACED, LEAD IMPEDANCE WAS REPORTEDLY OKAY. THERE WAS NO TRAUMA OR MANIPULATION THAT OCCURRED THAT IS BELIEVED TO HAVE CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. THE EXPLANT HOSPITAL DOES NOT RETURN EXPLANTED PRODUCTS BACK TO THE MANUFACTURER PER HOSPITAL POLICY. THEY DISCARD IN SURGERY. THEREFORE, ANALYSIS IS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    AFTER THE LEAD WAS ALSO REPLACED ON (B)(6) 2014, LEAD IMPEDANCE WAS REPORTEDLY OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697273 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200560

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention