BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER)

    MDR report key: 21617911 · Received March 17, 2025

    Report

    Report Number
    2184149-2025-00051
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 17, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067003126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. UDI INFORMATION (D4) AND 510K (G3) ARE NOT PROVIDED WITHIN THIS REPORT AS THIS PRODUCT (MODEL 09-1462-0056) IS AN OUS CONFIGURATION NOT AVAILABLE IN THE US AND IS THEREFORE NOT REFERENCED IN THE GUDID DATABASE.

    Description of Event or Problem · 0

    DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. WHEN THE CATHETERS WERE PLACED IN THE PATIENT, IT WAS REPORTED THAT THE INTRACARDIAC SIGNALS WERE NOT VISIBLE ON THE WORKMATE CLARIS AMPLIFIER AND KEPT DISPLAYING BLUE LINES. ONLY ECG SIGNALS WERE SHOWN AS ECM WOULD NOT DISPLAY. ISSUE WAS NOT RESOLVED, THEREFORE THE CASE WAS CANCELED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WILL BE RESCHEDULED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283388 EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER) Computer, diagnostic, programmable DQK ST. JUDE MEDICAL, INC. 09-1462-0056 05415067003126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown