BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINIUM

    MDR report key: 19296494 · Received May 13, 2024

    Report

    Report Number
    1000165971-2024-00401
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 8, 2024
    Report Date
    July 10, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    NIK
    UDI-DI
    08031527014388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NIK - DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (CRT-D).

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. ANALYSIS OF PROVIDED DATA DATED 08 APRIL 2024 REVEALED: SINCE NOVEMBER 2017, ALL CHARGE TIME (MOSTLY FOR BATTERY REFORMING PURPOSE) WERE MEASURED BETWEEN 9 AND 10,3 SECONDS (NOMINAL TIME). - THE CHARGE TIME MEASURED AT 14 SECONDS, ON 08 APRIL 2024, DURING FOLLOWUP, IS NOT INDICATIVE OF AN ANOMALY. - NO OVERCONSUMPTION WAS MEASURED. - THE BATTERY VOLTAGE FOLLOWED A NOMINAL DISCHARGE CURVE, AND THE VOLTAGE OF 2.91V MEASURED IS CONSISTENT WITH A NORMAL BATTERY DISCHARGE. - ON 08 APRIL 2024, ACCORDING TO THE CURRENT LEVEL OF BATTERY (2,91V) AND CURRENT SETTINGS (VVIR 65BPM), THE ESTIMATED RESIDUAL LONGEVITY IS 170 WEEKS (3 YEARS 3 MONTHS), WHICH IS CONSISTENT WITH THE RESIDUAL LONGEVITY OF 3-5 YEARS GIVEN IN THE OVERVIEW. - BASED ON AVAILABLE DATA, NO ISSUE IS SUSPECTED ON THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    REPORTEDLY, THE DEVICE HAS A SHOWN RESIDUAL LONGEVITY OF 3-5 YEARS AS GIVEN IN THE OVERVIEW. THE CENTER SUSPECTS THAT THE DEVICE MIGHT REACH RRT SOONER AND UNEXPECTED THE CHARGE TIME IS 14 SECONDS ALREADY.

    Description of Event or Problem · 0

    REPORTEDLY, THE DEVICE HAS A SHOWN RESIDUAL LONGEVITY OF 3-5 YEARS AS GIVEN IN THE OVERVIEW. THE CENTER SUSPECTS THAT THE DEVICE MIGHT REACH RRT SOONER AND UNEXPECTED THE CHARGE TIME IS 14 SECONDS ALREADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842116 PLATINIUM DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON NIK MICROPORT CRM S.R.L. PLATINIUM SONR CRT-D 1811 08031527014388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown