BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 23222446 · Received October 6, 2025

    Report

    Report Number
    2124215-2025-70397
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    August 22, 2025
    Report Date
    February 18, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608. 01 - THE SUPPLEMENTAL WAS OPENED TO REPORT THE PRODUCT ANALYSIS RESULTS OF THE DEVICE RETURNED. COMPLAINT INVESTIGATION INDICATES THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC, BASED ON ANALYSIS OF THE RETURNED PRODUCT. ANALYSIS FOUND NO EVIDENCE OF DEVICE DEFECT, MALFUNCTION OR DAMAGE OUTSIDE THE BOUNDS OF NORMAL MEDICAL USE (VISUAL INSPECTION FOUND NO ANOMALIES, DEVICE RECEIVED WITH NO TELEMETRY AND REVIEW OF LATITUDE DATA FOUND NO SUSPICIOUS SYSTEM ERRORS OR FAULTS, DEVICE MEETS LABELED LONGEVITY). BASED ON THE RESULTS OF THE INVESTIGATION, NO ESCALATION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CEREBROVASCULAR ACCIDENT PRESENTED WITH DISCOMFORT RELATED TO AN INSERTABLE CARDIAC MONITOR (ICM). DUE TO ONGOING SYMPTOMS, THE PATIENT REQUESTED DEVICE REMOVAL AND REQUESTED ICM REMOVAL. ADDITIONALLY, THE ICM HAD REACHED EFFECTIVE REPLACEMENT STATUS APPROXIMATELY THREE YEARS AND SIX MONTHS AFTER IMPLANTATION. BATTERY DEPLETION WAS CONSISTENT WITH THE EXPECTED SERVICE LIFE, CONFIRMING NORMAL DEVICE USAGE. THE ICM WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CEREBROVASCULAR ACCIDENT PRESENTED WITH DISCOMFORT RELATED TO AN INSERTABLE CARDIAC MONITOR (ICM). DUE TO ONGOING SYMPTOMS, THE PATIENT REQUESTED DEVICE REMOVAL AND REQUESTED ICM REMOVAL. ADDITIONALLY, THE ICM HAD REACHED EFFECTIVE REPLACEMENT STATUS APPROXIMATELY THREE YEARS AND SIX MONTHS AFTER IMPLANTATION. BATTERY DEPLETION WAS CONSISTENT WITH THE EXPECTED SERVICE LIFE, CONFIRMING NORMAL DEVICE USAGE. THE ICM WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608801 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIA MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 140126 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H