BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINIUM

    MDR report key: 18170062 · Received November 20, 2023

    Report

    Report Number
    1000165971-2023-00948
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    February 16, 2023
    Report Date
    November 20, 2023
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF PROVIDED DATA HIGHLIGHTED DOUBLE COUNTING OF THE QRS DURING THE RECORD OF TWO (2) NON-SUSTAINED VENTRICULAR TACHYCARDIA. THESE 2 NON-SUSTAINED VENTRICULAR TACHYCARDIAS PRESENTED WITH WIDE QRS. WHEN THE QRS IS WIDE, THE TOP OF THE QRS MAY BE SENSED OUT OF THE 64 MS QRS MEASUREMENT WINDOW: THE PART OF THE QRS THAT IS SENSED IN THE 64 MS QRS MEASUREMENT WINDOW IS LOWER THAN THE TOP OF THE QRS. THEREFORE, THE AUTOMATIC SENSITIVITY CONTROL CALCULATES LOWER SENSITIVITY VALUES THAN IT SHOULD HAVE CALCULATED IF THE TOP OF THE QRS HAD BEEN MEASURED WITHIN THE 64 MS QRS MEASUREMENT WINDOW. LOWER SENSITIVITY STEPS MAY PROMOTE DOUBLE COUNTING OF THE QRS IN THE EVENT OF WIDE QRS. NO GENERAL MALFUNCTION IS SUSPECTED ON THE DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TREND PURPOSES.

    Description of Event or Problem · 0

    REPORTEDLY, DURING A STANDARD FOLLOW UP, IN AIDA EGMS THERE WAS A NON SUSTAINED ARRHYTHMIA THAT SHOWED DOUBLE COUNTED/MARKED QRS COMPLEXES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165571 PLATINIUM DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MICROPORT CRM S.R.L. PLATINIUM CRT-D 1711

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown