BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5047166 · Received September 1, 2015

    Report

    Report Number
    2134265-2015-05725
    Event Type
    Death
    Date Received
    September 1, 2015
    Date of Event
    May 14, 2015
    Report Date
    August 3, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DEATH OCCURRED. IN (B)(6) 2013, THE PATIENT HAD A WATCHMAN ® LAA CLOSURE DEVICE IMPLANTED SUCCESSFULLY. THE PATIENT WAS PLACED IN HOSPICE ON AN UNKNOWN DATE. THE PATIENT DIED IN (B)(6) 2015 DUE TO AN UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578261 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS24060

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death