BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOT DX¿ ICM

    MDR report key: 18564614 · Received January 23, 2024

    Report

    Report Number
    2017865-2024-01685
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 16, 2024
    Report Date
    October 7, 2024
    Manufacturer
    ABBOTT
    Product Code
    MXC
    UDI-DI
    05415067040046
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF INABILITY TO INTERROGATE COULD NOT BE CONFIRMED. THE DEVICE WAS RECEIVED WITH AN ERROR MESSAGE SCREEN UPON INTERROGATION. DEVICE IMAGE INDICATED THE BATTERY VOLTAGE WAS AT END OF SERVICE (EOS). ANALYSIS PERFORMED, INCLUDING A SOFTWARE INVESTIGATION, INDICATED THE DEVICE WAS WORKING AS DESIGNED IN DISPLAYING THE MESSAGE BECAUSE THE DEVICE IS IN SHIPPED SETTINGS WITH A STATUS OF EOS. THE ROOT CAUSE FOR THE EOS WAS IDENTIFIED TO BE THE INCORRECT PROGRAMMING OF BATTERY SLOPE TRIM RESULTING IN CALCULATED VOLTAGE BEING LOWER THAN THE ACTUAL VOLTAGE. TESTS SHOWED ACTUAL BATTERY VOLTAGE TO BE AT NORMAL LEVEL. LONGEVITY ASSESSMENT WAS PERFORMED AND DEVICE WAS IN THE NORMAL RANGE OF OPERATION WITH APPROPRIATE REMAINING LONGEVITY. AN ERROR MESSAGE BEING DISPLAYED ON THE PROGRAMMER WHEN INTERROGATING THE DEVICE WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE PROGRAMMER SOFTWARE WAS WORKING AS DESIGNED AND DISPLAYING THIS MESSAGE BECAUSE THE DEVICE IS IN SHIPPED SETTING WITH A STATUS OF EOS, INDICATING IT IS NOT GOOD FOR IMPLANT. THE ROOT CAUSE WAS IDENTIFIED TO BE THE INCORRECT PROGRAMMING OF BATTERY SLOPE TRIM RESULTING IN CALCULATED VOLTAGE BEING LOWER THAN THE ACTUAL VOLTAGE, MOVING THE DEVICE TO EOS STATUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR IMPLANT, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PATIENT HAD NOT YET ENTERED THE PROCEDURE ROOM. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648905 JOT DX¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ABBOTT DM4500 P000184856 05415067040046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown