BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5114924 · Received September 30, 2015

    Report

    Report Number
    2134265-2015-06755
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    November 16, 2014
    Report Date
    September 4, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED A DEATH OCCURRED. IN AUGUST 2014 A 30MM WATCHMAN¿ LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. IT WAS REPORTED THAT THE PATIENT DIED AT HOME IN NOVEMBER 2014. PER THE SITE, THE GENERAL PHYSICIAN STATED THAT THE PATIENT MOST LIKELY DIED DUE TO TERMINAL HEART INSUFFICIENCY AND TERMINAL RENAL INSUFFICIENCY. HOWEVER, THE GENERAL PHYSICIAN DID NOT SEE THE PATIENT. A DEATH CERTIFICATE IS NOT AVAILABLE; THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643769 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS30060 16979303

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death