BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7037200 · Received November 16, 2017

    Report

    Report Number
    2134265-2017-11373
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    March 1, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    M110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA MW # 5072593. IT WAS REPORTED VIA MEDWATCH THAT THE PATIENT HAD A WATCHMAN LAA CLOSURE DEVICE IMPLANTED ON (B)(6) 2017. IN (B)(6) 2017 IT WAS REPORTED THAT THE PATIENT RECENTLY EXPERIENCED BLEEDING, FLUID ON THE LUNGS AND A STROKE; SHE WAS UNABLE TO SPEAK OR MOVE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818330 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE UNK727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other