BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 12162948 · Received July 13, 2021

    Report

    Report Number
    1644487-2021-00946
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    April 23, 2021
    Report Date
    February 24, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10. MEDICAL DEVICE CODE- CORRECTION - CODE A040101 SHOULD HAVE BEEN UTILIZED INSTEAD OF CODE A072201. H6. INVESTIGATION FINDINGS - CORRECTION - CODE C070603 SHOULD HAVE BEEN UTILIZED INSTEAD OF CODE C0203. H6. INVESTIGATION CONCLUSIONS - CORRECTION - CODE D02 SHOULD HAVE BEEN UTILIZED INSTEAD OF CODE D14.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION FINDINGS - CORRECTION - CODE C0203 WAS INADVERTENTLY CODE ON SUPPLEMENTAL #5 MDR.

    Description of Event or Problem · 0

    THE EXPLANTED LEAD WAS RECEIVED AND PRODUCT ANALYSIS IS BEING PERFORMED.

    Description of Event or Problem · 0

    PIN REINSERTION WAS CONFIRMED BY XRAY AND VISUALLY IN SURGERY. LEAD REVISION WAS PERFORMED. ELECTRODES WERE CLIPPED AND REMOVED. NO OBVIOUS DEFECTS OR BREAKS WERE OBSERVE BY THE SURGEON. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PROGRAMMING DATA RECEIVED AND REVIEWED. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    LEAD ANALYSIS WAS COMPLETED AND LEAD DISCONTINUITIES WERE CONFIRMED. DURING THE VISUAL ANALYSIS THE RING AND PIN COIL ENDS OF 2ND PORTION OF LEAD WERE FOUND TO BE BROKEN. THE BREAK MATE FOR PIN COIL WAS FOUND ON 3RD PORTION AND THE RING COIL BREAK MATE WAS FOUND ON 4TH RETURNED PORTION.

    Description of Event or Problem · 0

    NEW IMPEDANCE VALUE AND SETTINGS WERE RECEIVED. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE IS SHOWING HIGH IMPEDANCE. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LEAD AND THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057924 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 202298

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male