BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENO

    MDR report key: 16713473 · Received April 11, 2023

    Report

    Report Number
    1000165971-2023-00284
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 13, 2023
    Report Date
    February 26, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    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. PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    CRM-SAL-2023-001 THE PACEMAKER WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2023, THE BATTERY IMPEDANCE WAS 2080OHMS. THE PACEMAKER REPLACEMENT PLANNED ON (B)(6) 2023.

    Description of Event or Problem · 0

    CRM-SAL-2023-001 THE PACEMAKER WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2023, THE BATTERY IMPEDANCE WAS 2080OHMS. THE PACEMAKER REPLACEMENT PLANNED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379966 ENO IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. ENO DR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown