BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER OPTIC ADPT DPX SC LC 625 125 1FT

    MDR report key: 16207166 · Received January 19, 2023

    Report

    Report Number
    2184149-2023-00013
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 19, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING THE ATRIAL FLUTTER PROCEDURE ABLATION DATA WAS NOT SENDING FROM THE AMPERE TO THE AMPLIFIER WHICH CAUSED THE PROCEDURE TO BE CANCELED. THE PROCEDURE WAS DELAYED UNTIL THE NEXT DAY. SWAPPING OUT THE SC/LC FIBER OPTIC CABLE RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130178 FIBER OPTIC ADPT DPX SC LC 625 125 1FT ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM DQK ST. JUDE MEDICAL, INC. ENSITE-FOADPT-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown