BEUDAMED
    FDA Adverse Event Other Summary report: N

    WATCHMAN

    MDR report key: 17923788 · Received October 11, 2023

    Report

    Report Number
    MW5146855
    Event Type
    Other
    Date Received
    October 11, 2023
    Date of Event
    January 4, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A REPEAT ABLATION (1ST ONE DID NOT WORK) AND INSERTION OF A WATCHMAN DEVICE. DURING THE PROCEDURE, I SUSTAINED A LARGE PERICARDIAL EFFUSION REQUIRING INSERTION OF A DRAINAGE TUBE AND EARLY CESSATION OF THE ABLATION. SINCE THAT TIME I HAVE SUFFERED WITH EXERTIONAL DYSPNEA. IN MAY, I FINALLY HAD AN ECHOCARDIOGRAM WHICH SHOWED SEVERE MR AND PULMONARY HTN (I DID NOT HAVE THESE PROBLEMS PRE-PROCEDURE). I HAVE CHANGED DOCTORS AND NEW DOCTOR IS DOING MORE TESTS BUT THINKS THAT I AM "HEADED TOWARDS MV REPLACEMENT SURGERY". I READ THAT IN 2021 THE FDA WAS DOING MORE SURVEILLANCE ON THE WATCHMAN IN THAT STATISTICAL DATA WAS SHOWING THAT THE PROCEDURE FOR WOMEN WAS MUCH MORE RISKY ¿ I WAS NEVER TOLD THIS. CBC: RBC: 2.9, HGB: 8.7, HCT: 26, CMP: GFR: 59 BNP: 271 CXR: (L) COSTOPHRENIC BLUNTING EKG: AF WITH RAPID VR CXR: SMALL BILATERAL PLEURAL EFFUSIONS NT PROBNP: 478 GFR: 54 CR: 1.12 CT ANGIOGRAM: SMALL (L) PLEURAL EFFUSION W/NEAR COMPLETE ATELECTASIS ON LLL ECHOCARDIOGRAM: MOD - SEVERE MVR, SIGNIFICANT PULMONARY HTN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038375 WATCHMAN SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 08714729860518 30099083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other| H BABY ASA DAILY.| CALCIUM.| FISH OIL.| LISINOPRIL 20 MG 2X/D. | VITAMIN C.| VITAMIN D.