BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 9354334 · Received November 21, 2019

    Report

    Report Number
    2134265-2019-14254
    Event Type
    Death
    Date Received
    November 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;11700937,,D,55;863,WATCHMAN LAA Closure Device & Delivery System,WU2406,2993

    Additional Manufacturer Narrative · 1

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS REPORT SUMMARIZES 1 PATIENT DEATH. DATE OF EVENT: UNKNOWN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED EVENTS AS PART OF THE LAAO/NCDR REGISTRY FOR THE WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICES, FALLING UNDER THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) DATA REGISTRY OF THE AMERICAN COLLEGE OF CARDIOLOGY'S NATIONAL CARDIOVASCULAR DATA REGISTRY (NCDR). THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028 FOR PRODUCT CODE NGV. THE DATA WAS DOWNLOADED 25 JULY 2019. THE REPORT SUMMARIZES 1 PATIENT DEATH OF AN UNKNOWN CAUSE 863 DAYS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149701 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371

    Patients

    Seq Age Sex Outcome Treatment
    1 Death