BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUX-DX? INSERTABLE CARDIAC MONITOR

    MDR report key: 21608351 · Received March 14, 2025

    Report

    Report Number
    2124215-2025-16062
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 21, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MXD
    UDI-DI
    00802526607103
    PMA / PMN Number
    K193473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608. THE EXACT EXPLANT DATE IS UNKNOW. THE DEVICE EXPLANT DATE FIELD D6B WAS FILLED WITH AN APPROXIMATE DATE. FOLLOW UP REPORT (1): THIS REPORT IS BEING SUBMITTED TO CORRECT GRID H6. IMPACT CODES. FOLLOW UP REPORT (2): THIS REPORT IS BEING SUBMITTED DUE ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME.

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608. THE EXACT EXPLANT DATE IS UNKNOW. THE DEVICE EXPLANT DATE FIELD D6B WAS FILLED WITH AN APPROXIMATE DATE. FOLLOW UP REPORT (1): THIS REPORT IS BEING SUBMITTED TO CORRECT GRID H6. IMPACT CODES.

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS 2 PREMARKET APPROVALS AND DUE TO SPACING LIMITATIONS ON FIELD G4 THEY ARE K193473 AND K210608. THE EXACT EXPLANT DATE IS UNKNOWN. THE DEVICE EXPLANT DATE FIELD D6B WAS FILLED WITH AN APPROXIMATE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS REMOVED DUE TO A REPORTED ALLERGIC REACTION; HOWEVER, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION CONFIRMS THAT DEVICE WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS REMOVED DUE TO A REPORTED ALLERGIC REACTION; HOWEVER, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONALLY, THE BOSTON SCIENTIFIC TERRITORY MANAGER HAS PROVIDED INFORMATION, STATING THAT HE DOES NOT HAVE ANY DETAILS ABOUT THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS REMOVED DUE TO A REPORTED ALLERGIC REACTION; HOWEVER, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433693 LUX-DX? INSERTABLE CARDIAC MONITOR INSERTABLE CARDIAC MONITOR MXD BOSTON SCIENTIFIC CORPORATION M301 196983 00802526607103

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Hospitalization| R