BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 17529764 · Received August 12, 2023

    Report

    Report Number
    MW5136688
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    July 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT OT A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-0), THE COMPETITOR LEFT VENTRICULAR (LV) LEAD COULD NOT BE TIGHTENED INTO THE DEVICE HEADER AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN NOTED THAT THE LEAD WAS TOO SMALL FOR THE DEVICE HEADER. THE LV LEAD WAS CAPPED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940097 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK BOSTON SCIENTIFIC 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown