BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOT DX¿ ICM

    MDR report key: 23390447 · Received October 27, 2025

    Report

    Report Number
    2017865-2025-1003441
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 6, 2025
    Report Date
    April 14, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    UDI-DI
    05415067040046
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS OF COMMUNICATION ANOMALIES AND INCORRECT MODEL NUMBER DISPLAYED WERE CONFIRMED. UPON RECEIPT, THE DEVICE COULD NOT BE INTERROGATED USING A MERLIN PROGRAMMER. FINAL ANALYSIS OF THE DEVICE IMAGE IDENTIFIED AN INCORRECT MODEL NUMBER STORED IN THE MEMORY REGISTERS. THE FIRMWARE WAS RELOADED, AND SUBSEQUENT ANALYSIS, INCLUDING ELECTRICAL AND TELEMETRY TESTING, DEMONSTRATED NORMAL DEVICE FUNCTIONALITY. BASED ON THE PROVIDED INFORMATION, IT WAS SEEN THAT THE MODEL NUMBER WAS SET TO 3100. THE ¿CANNOT INTERROGATE¿ DIALOG DISPLAYED BY THE PROGRAMMER IS EXPECTED AS THE MODEL NUMBER WAS NOT EITHER 3500 OR 4500 FOR THE CONFIRM RX OR JOT DX FAMILY DEVICES. THE PRESENCE OF AN INCORRECT MODEL NUMBER IN THE MEMORY REGISTERS IS CONSISTENT WITH FIRMWARE CORRUPTION AND ALIGNS WITH THE REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING JOTDX IMPLANT, THE INSERTABLE CARDIAC MONITOR (ICM) FAILED TO BE INTERROGATED VIA BLUETOOTH TELEMETRY, AND A MAGNET RESPONSE COULD NOT BE RECEIVED. THIS DEVICE WAS NOT USED FOR IMPLANT ON (B)(6) 2025. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2740571 JOT DX¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM4500 P000221734 05415067040046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown