BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT EL ICD DR

    MDR report key: 13477152 · Received February 7, 2022

    Report

    Report Number
    2124215-2022-03736
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    November 11, 2021
    Report Date
    February 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526587801
    PMA / PMN Number
    P960040/S385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENTS WERE IN THE 1,500-1,600 OHM RANGE. ALL OTHER MEASUREMENTS WERE WITHIN AN ACCEPTABLE RANGE. THE HIGH IMPEDANCE WAS SUSPECTED TO BE DUE TO A POOR CONNECTION. THE LEAD WAS REMOVED FROM THE HEADER AND REINSERTED WITH MEASUREMENTS IN THE 800-900 OHM RANGE. IMAGES WERE SENT FOR REVIEW WITH ARTIFACT NOTED. TECHNICAL SERVICES DISCUSSED THE ARTIFACT APPEARED TO BE AIR BUBBLES WHICH USUALLY RESOLVE IN 24 HOURS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850689 VIGILANT EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D233 605517 00802526587801

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female