BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEO DR

    MDR report key: 15484769 · Received September 26, 2022

    Report

    Report Number
    1000165971-2022-00411
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 21, 2022
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    DURING A PM REPLACEMENT, THE PHYSICIAN REPORTED THE PACEMAKER CAPTURE ON V WAS SUDDENLY GONE FOR LONGER PERIODS. REPORTEDLY, REPROGRAMMING LEADS TO BIPOLAR SOLVED THE PROBLEM.

    Description of Event or Problem · 0

    DURING A PM REPLACEMENT, THE PHYSICIAN REPORTED DURING POCKET CLOSURE,THE PACEMAKER CAPTURE ON V WAS SUDDENLY GONE FOR LONGER PERIODS. REPROGRAMMING LEADS TO BIPOLAR SOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928370 TEO DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MICROPORT CRM S.R.L. TEO DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown