BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 17616871 · Received August 24, 2023

    Report

    Report Number
    2124215-2023-44544
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    August 6, 2023
    Report Date
    August 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT : AWARE DATE WAS USED AS EVENT DATE AS ACTUAL EVENT DATE WAS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. IT WAS REPORTED THAT TWO (2) YEARS POST IMPLANT, THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS. THE PATIENT WAS REPORTED TO NOT BE ABLE TO EAT AND TALK. THE SYMPTOMS PERSISTED FOR TWO (2) DAYS AND THE PATIENT THEN RETURNED BACK TO BASELINE. THE PATIENT IS CURRENTLY BEDRIDDEN AND UNDER END-OF-LIFE HOSPICE CARE DUE TO OTHER HEALTH CONDITIONS. THE DIAGNOSIS OF A STROKE WAS NOT CONFIRMED AS IT WAS MADE BY A HOSPICE WORKER AND NOT A PHYSICIAN. THE PATIENT DID NOT GO TO THE HOSPITAL FOR ADDITIONAL CARE OR IMAGING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006689 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other