BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 22216378 · Received June 16, 2025

    Report

    Report Number
    2124215-2025-39592
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526540271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT ARRIVED AT THE HEALTH CARE FACILITY DUE TO EXPERIENCING FAINTING SENSATION AND DIZZINESS. ANALYSIS OF THIS IMPLANTABLE PACEMAKER WAS PERFORMED, AND IT WAS FOUND THAT THE BATTERY LONGEVITY HAS DECREASED MORE THAN EXPECTED. THE PATIENT WAS ADMITTED TO THE HEALTH CARE FACILITY FOR A REPLACEMENT PROCEDURE AND THE DAY OF THE REPLACEMENT; THIS PACEMAKER ENTERED IN SAFETY MODE. THE REPLACEMENT PROCEDURE WAS COMPLETED. THIS DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442860 INGENIO IMPLANTABLE PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION J177 101597 00802526540271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R