BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIZEA

    MDR report key: 24559085 · Received March 10, 2026

    Report

    Report Number
    1000165971-2026-000172
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    December 19, 2025
    Report Date
    March 10, 2026
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    DXY
    UDI-DI
    08031527008493
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCLUSIONS ARE AS FOLLOWS: - THE VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITY. THE ANALYSIS CONFIRMS THAT THE CONNECTION SYSTEM OF THE SUBJECT PACEMAKER FUNCTIONED AS SPECIFIED USING A DUPLICATE TORQUE-LIMITING SCREWDRIVER. - THE ATRIAL AND VENTRICULAR SILICONE CAPS WERE FOUND DAMAGED INDUCING A HOLE. - THE ATRIAL SETSCREW CAVITY WAS FOUND DAMAGED (ROUNDED) WITH THE PRESENCE OF A PIECE OF ATRIAL SILICONE CAP INSIDE THE CAVITY. - A CORRECT TIGHTENING MARK WAS NOTICED ON THE ATRIAL AND VENTRICULAR SETSCREW TIPS. - NEVERTHELESS, SEVERAL DAMAGES WERE OBSERVED ON THE ATRIAL SETSCREW TIP EXPLAINING THE ISSUE REPORTED IN THIS COMPLAINT. - THE MOST LIKELY HYPOTHESIS IS THAT TOO MUCH STRENGTH WAS APPLIED WITH THE SCREWDRIVER, ESPECIALLY ON THE ATRIAL CONNECTOR, LEADING TO DAMAGES ON THE SILICONE CAP, HEXAGONAL CAVITY AND THE SETSCREW TIP, INDUCING ABNORMAL SCREWING, ASSOCIATED PROBABLY WITH AN INCORRECT ALIGNMENT, AND FINALLY GENERATING THE DAMAGES OBSERVED. BASED ON THE AVAILABLE INFORMATION, NO ISSUE IS SUSPECTED ON THE SUBJECT PACEMAKER. A CORRECTION WAS DONE IN THIS MFR REPORT NUMBER FOLLOWING AN ERROR IN THE MFR REPORT NUMBERS: - THE INTIAL MDR WAS SENT THROUGH FOLLOW-UP 1, MFR REPORT NUMBER 1000165971-2026-00024, - THE CORRECTION IS DONE THROUGH THIS MFR REPORT NUMBER 1000165971-2026-000172. THROUGH THIS MFR REPORT NUMBER, INITIAL AND FINAL MDR ARE COMBINED INCLUDING THE CONCLUSIONS OF THIS CASE.

    Description of Event or Problem · 0

    REPORTEDLY, DURING THE PACEMAKER IMPLANTATION, IT WAS IMPOSSIBLE TO CONNECT THE ATRIAL LEAD : NO CLICK HEARD AFTER SCREWING IT IN. THE VENTRICULAR LEAD WAS CORRECTLY CONNECTED TO THE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620980 ALIZEA IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MICROPORT CRM S.R.L. ALIZEA DR 1600 08031527008493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown