BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 25311811 · Received May 28, 2026

    Report

    Report Number
    2124215-2026-28498
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    February 23, 2024
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM CONTAINS AN ADDITIONAL CODE - K193473, K210608; BOTH REPORTED HERE AS IT EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # FIELD ON 3500A FORM CONTAINS AN ADDITIONAL CODE - K193473, K210608; BOTH REPORTED HERE AS IT EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. PRODUCT RECORD REVIEWS DID NOT IDENTIFY A PRODUCT QUALITY ISSUE OR NEW PATIENT HARM. ANALYSIS OF AVAILABLE INFORMATION DID NOT IDENTIFY A SPECIFIC COMPLAINT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF COMMUNICATION OR TRANSMISSION ISSUE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "CAUSE NOT ESTABLISHED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) LAST TRANSMISSION WAS OVER 2 YEARS AGO. THE HEALTHCARE PROVIDER INDICATED THAT THEY THINK THAT THE BATTERY DEPLETED TWO YEARS AFTER INITIAL IMPLANT. THE HEALTHCARE PROVIDER WILL FOLLOW-UP WITH THE PATIENT TO CHECK IF THEY WANT THEIR ICM REPLACED. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) LAST TRANSMISSION WAS OVER 2 YEARS AGO. THE HEALTHCARE PROVIDER INDICATED THAT THEY THINK THAT THE BATTERY DEPLETED TWO YEARS AFTER INITIAL IMPLANT. THE HEALTHCARE PROVIDER WILL FOLLOW-UP WITH THE PATIENT TO CHECK IF THEY WANT THEIR ICM REPLACED. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386103 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 150702 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1