BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENO

    MDR report key: 24468471 · Received February 27, 2026

    Report

    Report Number
    1000165971-2026-00117
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 27, 2026
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    UDI-DI
    08031527008493
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. THE CONCLUSIONS ARE AS FOLLOWS: THE SUBJECT PACEMAKER SWITCHED IN STANDBY MODE ON (B)(6) 2025 FOLLOWING THE DETECTION OF A CORRUPTION IN DEVICE MEMORY DATA UPON MEMORY INTEGRITY SELF-CHECKS PERFORMED BY THE PROGRAMMER DURING THE DEVICE INTERROGATION. THE PROGRAMMER HAS REQUESTED THE SWITCH IN STANDBY MODE BECAUSE AT LEAST ONE BIT WAS CORRUPTED. THE ORIGIN OF THE UNEXPECTED DATA CORRUPTION COULD NOT BE IDENTIFIED WITH CERTAINTY. HOWEVER, THE MOST PROBABLE HYPOTHESIS IS AN ALTERATION OF THE MEMORY CONTENT BY A SEU (¿SINGLE EVENT UPSET¿ OR ¿BIT-FLIP¿ ¿ I.E. A CHANGE OF STATE OF ONE BIT) DUE TO THE INTERACTION BETWEEN THE MEMORY MICROCHIP AND A HIGH-ENERGY IONIZING PARTICLE. THIS IS A WELL KNOWN AND NON-DESTRUCTIVE PHENOMENON IN MICROELECTRONIC CIRCUITS. THE DEVICE RE-INITIALIZATION PROCESS WAS PROPERLY PERFORMED AND NORMAL PACEMAKER FUNCTIONING WAS RESTORED. AFTER RE-INITIALIZATION, THE SHIPPING VALUES ARE APPLIED (DDD; 60/130) AND IT IS AN EXPECTED BEHAVIOR. THE PHYSICIAN SUCCESSFULLY PROGRAMMED THE PARAMETERS AFTERWARDS. BASED ON THE AVAILABLE INFORMATION, NO ISSUE IS SUSPECTED ON THE SUBJECT PACEMAKER.

    Description of Event or Problem · 0

    REPORTEDLY, DURING A PACEMAKER CHECK AT AN OUTPATIENT CLINIC ON (B)(6) 2026, IT WAS DISCOVERED THAT THE SETTING OF THE ENO DR (S/N: (B)(6) HAD AUTOMATICALLY CHANGED FROM "SAFER-R70/130" TO "DDD60/130." "THE AIDA DIAGNOSTIC FUNCTION WAS ALSO FOUND TO BE TURNED OFF." CHEST DISCOMFORT DEVELOPED ON (B)(6) 2025. THE PATIENT, WHO HAD PREVIOUSLY BEEN ABLE TO WALK INDEPENDENTLY, PRESENTED TO THE HOSPITAL IN A WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51165 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO DR 08031527008493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown