BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19917942 · Received August 6, 2024

    Report

    Report Number
    2135147-2024-03803
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 4, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013480
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DYSPNEA AND ATRIAL FIBRILLATION A DAY AFTER IMPLANT WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: (B)(6) - ADVANCE LAA, PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 9133780) WAS IMPLANTED SUCCESSFULLY UTILIZING A 14F AMPLATZER STEERABLE DELIVERY SYSTEM. THE FOLLOWING DAY (B)(6) 2024, THE PATIENT DEVELOPED DYSPNEA AND ATRIAL FIBRILLATION. INTRAVENOUS LASIX WAS PROVIDED AND THE PATIENT WAS MONITORED OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661982 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9133780 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention| H