BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    MDR report key: 21398996 · Received February 18, 2025

    Report

    Report Number
    MW5166340
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Report Date
    December 12, 2024
    Manufacturer
    SORIN CRM SAS/MICROPORT CRM USA, INC.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD PRESENTED TO EMERGENCY ROOM (ER) WITH A HEARTRATE OF 25 BEATS PER MINUTE (8PM) AND RECORDED HIGH OUT OF RANGE PACING AND SHOCK IMPENDENCE MEASUREMENTS ON BOTH LV AND RIGHT VENTRICULAR (LV) CHANNELS. ADDITIONALLY, LOSS OF CAPTURE (LOC) AND MINUTE VENTILATION (MV) CHOP WAS NOTED. THE SUSPECTED CAUSE FOR THE LEAD ISSUES WERE EITHER UNINSERTED OR DISLODGMENT. TESTING WITH A PACING SYSTEM ANALYZER (PSA) SUGGESTED AN ISSUE WITH THE LEAD, BUT WHEN CONNECTED TO THE DEVICE, THE IMPEDANCE REMAINED OUT OF RANGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY THE FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387915 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK SORIN CRM SAS/MICROPORT CRM USA, INC. 1058T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other