BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 22080184 · Received May 23, 2025

    Report

    Report Number
    2124215-2025-33639
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD G4 PREMARKET/510K, FROM SECTION G ALL MANUFACTURERS, CONTAINS BOTH DOCUMENTS K193473 & K210608 WHOSE CHARACTER LIMIT PREVENTED BOTH ENTRIES FROM THE FIELD. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE DEVICE RETURN STATUS. AS OF TODAY, NO INFORMATION HAS BEEN RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE ERODED FROM THE SKIN OF THE PATIENT; DUE TO THIS REASON, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE THEIR ICM DEVICE EXPLANTED. OUTPATIENT ANTIBIOTICS WERE GIVEN TO THEM, TO TREAT A SUSPECTED INFECTION. A FEW WEEKS LATER, A DIFFERENT ICM DEVICE WAS IMPLANTED IN THE PATIENT AS REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED ICM DEVICE HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069971 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 135510 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| H