BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 16112403 · Received January 6, 2023

    Report

    Report Number
    1644487-2023-00015
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 14, 2022
    Report Date
    May 19, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT NOTE THAT THE EXPLANTED DEVICES HAD BEEN RECEIVED. D9 DEVICE AVAILABLE FOR EVALUATION? CORRECTED DATA: INITIAL REPORT INADVERTENTLY MARKED NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BATTERY REPLACEMENT WITH THE NEW GENERATOR THE DEVICE SHOWED HIGH IMPEDANCE. PIN-REINSERTION AND A TUG TEST WAS PERFORMED. DURING THE TUG-TEST, THE SILICON PORTION OF THE LEADS GOT STRIPPED EXPOSING THE BARE WIRE. IT WAS THEN NOTED THAT PATIENT WILL NOT HAVE A FULL REVISION DURING THE CALL. PATIENT WILL BE CLOSED AND LEADS WILL BE CUT SO THAT NO EXPOSED WIRE WILL BE DIRECTLY IN CONTACT WITH TISSUE. IT WAS CONFIRMED THAT HIGH IMPEDANCE WAS NOT OBSERVED IN PRE-OP AND ONLY ONCE THE NEW GENERATOR WAS CONNECTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT REVISION SURGERY WAS SUCCESSFUL AND SYSTEM WAS WITHIN NORMAL LIMITS. IT WAS NOTED THAT WHEN PHYSICIAN WENT TO FEEL INSIDE OF THE POCKED, HE STARTED PULLING OUT PIECES OF FLAT PLASTIC WHICH THEY WERE SHOCKED BY. TC STATED THAT SURGEON DID NOT THINK IT WAS ANYTHING TO DO WITH US (LIVANOVA) OR EVEN A PIECE OF THE DEVICE, BUT IT WAS ODD. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    INTERNAL DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED. THE RECEIVED TABLET DATA CONTAINED PROGRAMMING HISTORY FROM 12/14/2022. FROM THE DATE IN QUESTION, 12/14/2022 THE PHYSICIAN RAN 3 SYSTEM DIAGNOSTICS WHICH ALL RESULTED IN THE LEAD IMPEDANCE BEING HIGH. TIME; DIAGNOSTICS; LEAD IMPEDANCE. 12/14/22 10:33 AM; SYSTEM; 9000 OHMS. 12/14/22 11:39 AM; SYSTEM ; 9000 OHMS. 12/14/22 11:39 AM ; SYSTEM ; 9000 OHMS.

    Description of Event or Problem · 0

    THE EXPLANTED DEVICES WERE RECEIVED TO UNDERGO PRODUCT ANALYSIS. PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED LEAD. NOTE THAT SINCE A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. THE HIGH IMPEDANCE ALLEGATIONS WERE NOT CONFIRMED IN THE RETURNED LEAD PORTIONS. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED DURING THE FUNCTIONAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. TWO HALF SETS OF SETSCREW MARKS WERE FOUND NEAR THE END TIP OF THE CONNECTOR PIN, INDICATING THE LEAD CONNECTOR HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE PULSE GENERATOR AT LEAST TWICE. THE LOCATION OF THE ADDITIONAL FULL SET OF SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME THE LEAD CONNECTOR PIN WAS INSERTED COMPLETELY, AND A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. NO ANOMALIES PREVENTING THE CONNECTOR PIN FROM BEING FULLY INSERTED INTO THE GENERATOR WERE NOTED. THOUGH NOT CONCLUSIVE, AN IMPROPER LEAD INSERTION MAY BE A CONTRIBUTING FACTOR FOR ¿EXPLANTED, DUE TO LEAD BREAK / HIGH IMPEDANCE¿. THE ABRADED INSULATION ALLEGATIONS WERE PARTIALLY CONFIRMED IN THE RETURNED LEAD PORTIONS. DURING THE VISUAL ANALYSIS, ABRASIONS WERE OBSERVED ON CONNECTOR BOOT AND OUTER TUBING AT VARIOUS AREAS; THE ABRASIONS DID NOT PENETRATE. ADDITIONALLY, DURING THE VISUAL ANALYSIS, THE LARGE CONNECTOR BOOT WAS FOUND TO BE TORN OFF AT RING/BACKFILL INTERFACE. LEAD CONNECTOR DIMENSIONS FOR PIN, RING, SMALL BOOT O-RINGS AND LARGE BOOT O-RINGS WERE MEASURED AND NO ANOMALIES THAT COULD PREVENT PROPER INSERTION OR REMOVAL OF LEAD INTO GENERATOR HEADER WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST ANY DEVICE-RELATED ANOMALY WITH THE RETURNED LEAD WHICH MAY HAVE CONTRIBUTED TO TORN CONNECTOR BOOT.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR THAT WAS OPENED BUT NOT USED. AN INTERROGATION, SYSTEM DIAGNOSTIC TESTS, AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393017 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 203922 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male