BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 12824254 · Received November 16, 2021

    Report

    Report Number
    1644487-2021-01602
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 22, 2021
    Report Date
    June 28, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    F10. MEDICAL DEVICE CODE- CORRECTION - CODE A040101 SHOULD HAVE BEEN INCLUDED IN INITIAL MDR IN PLACE OF CODE A072201. H5. INVESTIGATION FINDINGS - CORRECTION - CODE C070603 SHOULD HAVE BEEN INCLUDED IN INITIAL MDR IN PLACE OF CODE C0203. H5. INVESTIGATION CONCLUSIONS - CORRECTION - CODE D02 SHOULD HAVE BEEN INCLUDED IN INITIAL MDR IN PLACE OF CODE D14.

    Description of Event or Problem · 0

    PATIENT WAS SEEN AND THE GENERATOR SHOWED HIGH IMPEDANCE WHEN INTERROGATED. PROGRAMMED OUTPUT CURRENT WAS UNABLE TO BE DELIVERED. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    PATIENT IS STILL EXPERIENCING HIGH IMPEDANCE. XRAYS WERE TAKEN; HOWEVER, NO ISSUES WERE OBSERVED. PATIENT WAS NOTED TO STILL BE FEELING STIMULATION. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT LEAD REPLACEMENT DUE TO HIGH IMPEDANCE. THE REPLACEMENT RESOLVED THE HIGH IMPEDANCE. THE EXPLANTED LEAD WAS RETURNED AND RECEIVED FOR ANALYSIS, THOUGH HAS NOT BEEN COMPLETED YET. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    LEAD ANALYSIS WAS COMPLETED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717630 LEAD MODEL 303 LEAD MUZ LIVANOVA USA, INC. 303-20 202089

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male