BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16912090 · Received May 11, 2023

    Report

    Report Number
    2124215-2023-19396
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - AWARE DATE OF 20APR2023 USED AS EVENT DATE IS UNKNOWN. IMPLANTING FACILITY: (B)(6).

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - AWARE DATE OF (B)(6) 2023 USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC AND REPORTED AS A MEDICAL DEVICE REPORT WHEN THE EVENT OCCURRED. IT WAS REPORTED VIA SOCIAL MEDIA THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). AT AN UNSPECIFIED TIME PERI OR POST PROCEDURALLY, A DEVICE LEAK WAS IDENTIFIED. THE PATIENT REPORTED PERSISTENT FATIGUE AND DIZZINESS AND WAS INSTRUCTED TO CONTINUE TAKING CLOPIDOGREL.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT ORIGINATED FROM SOCIAL MEDIA, AND THEREFORE DESPITE GOOD FAITH EFFORTS THE INFORMATION IS OFTEN INCOMPLETE. ADDITIONALLY, DUE TO THE LIMITED INFORMATION RECEIVED THROUGH GOOD FAITH EFFORTS, THIS EVENT MAY REPRESENT A DUPLICATE OF AN EVENT WHICH WAS ALREADY KNOWN TO BOSTON SCIENTIFIC AND REPORTED AS A MEDICAL DEVICE REPORT WHEN THE EVENT OCCURRED. IT WAS REPORTED VIA SOCIAL MEDIA THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). AT AN UNSPECIFIED TIME PERI OR POST PROCEDURALLY, A DEVICE LEAK WAS IDENTIFIED. THE PATIENT REPORTED PERSISTENT FATIGUE AND DIZZINESS AND WAS INSTRUCTED TO CONTINUE TAKING CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351248 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 Male Other