BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINIUM

    MDR report key: 23003643 · Received September 9, 2025

    Report

    Report Number
    1000165971-2025-00590
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    July 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    NIK
    UDI-DI
    08031527014524
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE AVAILABLE PATIENT FILES REVEALED: O AN ABNORMAL BATTERY DEPLETION O NO OVERCONSUMPTION - THE EXPERTISE OF THE RETURNED CRTD DIDN¿T REVEAL OVER-CONSUMPTION. THE BATTERY ANALYSIS REVEALED 2 CLUSTERS WERE FOUND INSIDE THE BATTERY. BOTH CLUSTERS WERE IN CONTACT WITH THE CATHODE BRIDGE, AND LEAD TO THE FAST BATTERY DEPLETION. - THE BATTERY FAILURE IS THE ROOT CAUSE OF THE FAST BATTERY DEPLETION.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE AVAILABLE PATIENT FILES REVEALED: O AN ABNORMAL BATTERY DEPLETION O NO OVERCONSUMPTION - THE EXPERTISE OF THE RETURNED CRTD DIDN'T REVEAL OVER-CONSUMPTION. - THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. THE MOST LIKELY HYPOTHESIS WOULD BE A BATTERY FAILURE. FURTHER INVESTIGATIONS ARE ONGOING AT THE BATTERY MANUFACTURER LEVEL.

    Description of Event or Problem · 0

    REPORTEDLY, A PREMATURE BATTERY DEPLETION IS SUSPECTED. THE SUBJECT DEFIBRILLATOR IS NOT INTERROGABLE ANYMORE. ON THE REMOTE MONITORING REPORT DATED ON (B)(6) 2025, THE BATTERY VOLTAGE WAS 2.79V AND 2.03 EARLY AUGUST.

    Description of Event or Problem · 0

    REPORTEDLY, A PREMATURE BATTERY DEPLETION IS SUSPECTED. THE SUBJECT DEFIBRILLATOR IS NOT INTERROGABLE ANYMORE. ON THE REMOTE MONITORING REPORT DATED 8TH JULY 2025, THE BATTERY VOLTAGE WAS 2.79V AND 2.03 EARLY (B)(6).

    Description of Event or Problem · 0

    REPORTEDLY, A PREMATURE BATTERY DEPLETION IS SUSPECTED. THE SUBJECT DEFIBRILLATOR IS NOT INTERROGABLE ANYMORE. ON THE REMOTE MONITORING REPORT DATED 8TH JULY 2025, THE BATTERY VOLTAGE WAS 2.79V AND 2.03 EARLY AUGUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068053 PLATINIUM DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MICROPORT CRM S.R.L. PLATINIUM 4LV SONR CRT-D 1844 08031527014524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R