BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4060401 · Received September 4, 2014

    Report

    Report Number
    1644487-2014-02213
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 25, 2018
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT INCLUDE DEVICE DISABLEMENT.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: FOLLOW-UP REPORT #02 INADVERTENTLY REPORTED THAT THE EXPLANTED DEVICES WERE NOT RETURNED TO THE MANUFACTURER. DEVICE AVAILABLE FOR EVALUATION, CORRECTED DATA: FOLLOW-UP REPORT #02 INADVERTENTLY REPORTED THAT THE EXPLANTED DEVICES WERE NOT RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS FOUND THAT HIGH IMPEDANCE WAS DETECTED ON SYSTEM DIAGNOSTICS ON (B)(6) 2014. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. X-RAYS WERE TAKEN AND PROVIDED TO THE MANUFACTURER FOR REVIEW. BASED ON THE X-RAYS RECEIVED, THE CAUSE FOR THE REPORTED HIGH IMPEDANCE CANNOT BE FULLY DETERMINED. THERE WAS NOTHING SEEN THAT WOULD INDICATE THERE WAS ANY DAMAGE TO THE GENERATOR OR LEAD; HOWEVER, THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. DUE TO IMAGE QUALITY THERE WERE SMALL PORTIONS OF THE LEAD THAT WERE DIFFICULT TO VISUALIZE AND FULLY ASSESS.

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE WAS PROGRAMMED OFF DUE TO THE HIGH LEAD IMPEDANCE. THE PATIENT WAS REFERRED FOR SURGERY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED LEAD AND GENERATOR WERE RECEIVED BY THE MANUFACTURER FOR ANALYSIS. ANALYSIS WAS APPROVED FOR THE RETURNED LEAD. A SECTION OF THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS IN ONE PIECE. NOTE THAT SINCE A PORTION OF THE LEAD WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE CONNECTOR PIN EXISTED AT LEAST ONCE. NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS WAS APPROVED FOR THE RETURNED GENERATOR. THE LOW BATTERY VOLTAGE 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. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT LEAD AND GENERATOR REPLACEMENT SURGERY. PER HOSPITAL POLICY, THE EXPLANTED DEVICES WERE NOT RETURNED TO THE MANUFACTURER. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542436 LEAD MODEL 302 LEAD LYJ LIVANOVA USA, INC. 302-20 6312

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR