BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 11946595 · Received June 4, 2021

    Report

    Report Number
    MW5101734
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC V173 CRT PACEMAKER SWITCHED TO SAFETY MODE. PATIENT IS PACEMAKER DEPENDENT. PATIENT LIVES IN (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833134 BOSTON SCIENTIFIC PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION V173

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other