BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 12399342 · Received August 31, 2021

    Report

    Report Number
    1644487-2021-01229
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 5, 2021
    Report Date
    November 17, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10. ADVERSE EVENT PROBLEM, CORRECTED DATA: THE INITIAL MDR INADVERTENTLY REPORTED MEDICAL DEVICE PROBLEM CODE A26 (INSUFFICIENT INFORMATION) INSTEAD OF A072202 ( LOW IMPEDANCE).

    Description of Event or Problem · 0

    THE EXPLANTED LEAD WAS RECEIVED FOR ANALYSIS. ANALYSIS ON THE EXPLANTED PRODUCT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETE ON THE RETURNED LEAD. AN ABRADED OPENING WAS NOTED IN THE TUBING OF THE LEAD RESULTING IN PORTION OF THE NEGATIVE COIL BEING EXPOSED AND AN ABRADED/TEAR OPENING BETWEEN THE POSITIVE AND THE NEGATIVE COILS. THE LEAD ASSEMBLY HAD DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENING AND THE CUT/TORN END OF THE RETURNED LEAD PORTION. NOTE THAT SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCE WAS SEEN ON THE PATIENT'S DEVICE. IT WAS REPORTED THAT THERE WAS NO TRAUMA TO THE LEAD. IMPEDANCE WAS FLUCTUATING FROM LOW TO OK IMPEDANCE. THE PATIENT UNDERWENT SURGERY AND THEIR LEAD WAS REPLACED. DURING SURGERY, THE SURGEON NOTED AN OPENING IN THE LEAD TUBING. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299562 LEAD MODEL 303 LEAD LYJ LIVANOVA USA, INC. 303-20 3369

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male