BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 2780290 · Received October 10, 2012

    Report

    Report Number
    1644487-2012-02572
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    April 5, 2012
    Report Date
    September 12, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 WHEN THE GENERATOR WAS RECEIVED FOR PRODUCT ANALYSIS. IN THE PRODUCT ANALYSIS 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. THE DATA IN THE MEMORY LOCATIONS REVEALED THAT 7.179% OF THE BATTERY HAD BEEN CONSUMED. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. IT WAS NOTED THAT THE HIGH IMPEDANCE WAS OBSERVED WITH AN IMPEDANCE VALUE OF 21683 OHMS AT SOME POINT PRIOR TO (B)(6) 2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS DISCOVERED THAT THE PATIENT UNDERWENT A LEAD REVISION AND A CUT WAS FOUND IN THE LEAD. THE PATIENT'S GENERATOR STILL DID NOT WORK WITH THE NEW LEAD AND THEREFORE IT WAS REPLACED (REPORTED ON MFR REPORT # 1644487-2012-02573) AND IS NOW WORKING. NO X-RAYS WERE TAKEN. THE SURGEON WAS NOT AWARE OF ANY PATIENT MANIPULATION OR TRAUMA THAT OCCURRED. THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND A SYSTEM DIAGNOSTICS TEST PERFORMED ON (B)(6) 2012 SHOWED HIGH IMPEDANCE. ATTEMPTS FOR THE RETURN OF THE EXPLANTED PRODUCT ARE UNDERWAY BUT THE EXPLANTED PRODUCTS HAVE NOT YET BEEN RETURNED FOR PRODUCT ANALYSIS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR