BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTIO

    MDR report key: 18354856 · Received December 19, 2023

    Report

    Report Number
    2124215-2023-72088
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    December 4, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP IT WAS DISCOVERED THAT THIS PACEMAKER WAS IN SAFETY MODE. THE DEVICE WAS REPLACED AND IS NOT EXPECTED O BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472927 ADVANTIO IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION J067 100420

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention| H