BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 8579555 · Received May 3, 2019

    Report

    Report Number
    2134265-2019-04850
    Event Type
    Death
    Date Received
    May 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 19, 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

    Additional Manufacturer Narrative · 0

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUPPLEMENTAL REPORT IS BEING FILED AS REQUESTED BY FDA TO INCLUDE CODES IN THE MARKER 3500A. THIS REPORT SUMMARIZES 4 PATIENT DEATHS. THE SUBMISSION WAS REQUESTED ON 07 NOVEMBER 2019. DATE OF EVENT: UNKNOWN.

    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;10976112,,D,386;457,WATCHMAN LAA Closure Device & Delivery System,WU2706,2993;10976063,,D,664,WATCHMAN LAA Closure Device & Delivery System,WU2406,2993;10976572,,D,662,WATCHMAN LAA Closure Device & Delivery System,WU3006,2993;10975978,,D,Unk,WATCHMAN LAA Closure Device & Delivery System,WU2706,2993

    Description of Event or Problem · 0

    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) 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 11 JANUARY 2019. PLEASE SEE SPREADSHEET DUE 11 MAY 2019.

    Additional Manufacturer Narrative · 1

    SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUMMARY REPORT REPRESENTS 4 PATIENT DEATH EVENTS.

    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) REGISTRY OF THE AMERICAN COLLEGE OF CARDIOLOGY'S NATIONAL CARDIOVASCULAR DATA REGISTRY (NCDR). REGISTRY. THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028 FOR PRODUCT CODE NGV. THE DATA WAS DOWNLOADED 11 JANUARY 2019, DUE 11 MAY 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373217 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371

    Patients

    Seq Age Sex Outcome Treatment
    1 Death