BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOT DX¿ ICM

    MDR report key: 17863487 · Received October 3, 2023

    Report

    Report Number
    2017865-2023-47638
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 7, 2023
    Manufacturer
    ABBOTT
    Product Code
    MXC
    UDI-DI
    05415067040046
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF REQUIRING A MAGNET TO BE PLACED OVER THE DEVICE IN ORDER TO SEND A TRANSMISSION WAS NOT CONFIRMED. THE PATIENT WAS ABLE TO SUCCESSFULLY SEND A TRANSMISSION WITHOUT THE PLACEMENT OF A MAGNET, ALTHOUGH THE TRANSMISSION TOOK A LONGER THAN ANTICIPATED FOR THE PATIENT. THE PATIENT APP LOGS WERE REVIEWED AND IT WAS OBSERVED THAT THERE WAS A CONNECTION TIMEOUT WITH THE IOS APPLICATION. THE ROOT CAUSE FOR THIS CONNECTION TIMEOUT IS NOT ABLE TO BE DETERMINED, ALTHOUGH IT IS SUSPECTED THAT THE PATIENTS ENVIRONMENT OR ANOTHER BLUETOOTH DEVICE MAY HAVE AN INFLUENCE ON THE PATIENT APPLICATION. IT IS PER DEVICE DESIGN THAT THE JOT DX ADVERTISES EVERY 4 MINUTES, AND IF THAT WINDOW IS MISSED, THE PATIENT WILL NEED TO WAIT ANOTHER 4 MINUTES TO ATTEMPT CONNECTION.

    Description of Event or Problem · 0

    DURING AN IN CLINIC FOLLOW UP, THE DEVICE WAS UNABLE TO BE INTERROGATED USING BLUETOOTH (BLE) TELEMETRY. A MAGNET WAS USED TO ACTIVATE THE BLE AND INTERROGATION WAS SUCCESSFUL. FOLLOWING THE SUCCESSFUL IN CLINIC INTERROGATION, THE DEVICE WAS ATTEMPTED TO BE INTERROGATED USING BLE FROM THE PHONE APPLICATION AND WAS UNSUCCESSFUL. A MAGNET WAS AGAIN USED TO ACTIVATE THE BLE AND THE DEVICE WAS ABLE TO SEND A SUCCESSFUL TRANSMISSION FROM THE PHONE APPLICATION. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED FURTHER INVESTIGATION. THE PATIENT WAS STABLE AND WILL CONTINUE BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761444 JOT DX¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ABBOTT DM4500 P000169177 05415067040046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown