BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIZEA

    MDR report key: 20912641 · Received December 12, 2024

    Report

    Report Number
    1000165971-2024-01144
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 19, 2024
    Report Date
    February 5, 2025
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    DXY
    UDI-DI
    08031527018591
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF PROVIDED DATA CONFIRMED THE REPORTED EVENT: THE ALERT FOR V BURST WAS TRIGGERED ON (B)(6) 2024 AND NO V BURST EPISODE WAS AVAILABLE IN THE DEVICE MEMORY. THE DATA FROM THE REMOTE FOLLOW-UP ON (B)(6) 2024 WERE PROVIDED. WHEN A V BURST IS DETECTED, IT TRIGGERS: THE RECORD OF A MARKER CHAIN. THE MARKER CHAIN WILL BE RECORDED AND THEN DISPLAYED IN AIDA FOLLOWING THE PRIORITY RULES TO RECORD A V BURST. THE ALERT FOR V BURST IF THE PROGRAMMED LOW LIMIT IS REACHED (LOW LIMIT IS 1 FOR THE SUBJECT DEVICE) THE INVESTIGATION OF THE PROVIDED DATA REVEALED THAT THE ALERT FOR V BURST WAS RAISED ON (B)(6) 2024 AT 21:41:18. IT ALSO REVEALED THAT ON (B)(6) 2024, THE DEVICE DETECTED 37 SAFER EPISODES. THE MOST PROBABLE HYPOTHESIS IS THAT THE DEVICE WAS ALREADY RECORDING A SAFER EPISODE WHEN THE V BURST WAS DETECTED AND THE DETECTION OF A V BURST DOES NOT STOP THE RECORDING OF A SAFER EPISODE, THEREFORE THE V BURST COULD NOT BE RECORDED IN AIDA. NO GENERAL MALFUNCTION IS SUSPECTED ON THE SUBJECT DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TREND PURPOSES.

    Description of Event or Problem · 0

    REPORTEDLY, THE CENTER RECEIVED A REMOTE REPORT FOR OCCURRENCE OF V BURST. NO EPISODE OF V BURST IS RECORDED IN THE DEVICE MEMORY NOR ON THE REMOTE WEBSITE.

    Description of Event or Problem · 0

    REPORTEDLY, THE CENTER RECEIVED A REMOTE REPORT FOR OCCURRENCE OF V BURST. NO EPISODE OF V BURST IS RECORDED IN THE DEVICE MEMORY NOR ON THE REMOTE WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203974 ALIZEA IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MICROPORT CRM S.R.L. ALIZEA DR 1600 08031527018591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown