BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULYS

    MDR report key: 19644032 · Received July 1, 2024

    Report

    Report Number
    1000165971-2024-00538
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 21, 2024
    Report Date
    October 31, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    MRM
    UDI-DI
    08031527018492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE AVAILABLE PATIENT FILES DATED ON (B)(6) 2024, REVEALED: OAN ABNORMAL BATTERY DEPLETION ONO OVERCONSUMPTION. THE EXPERTISE OF THE RETURNED ICD 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.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED REPORT - ANALYSIS OF THE AVAILABLE PATIENT FILES DATED (B)(6) 2024 REVEALED: OAN ABNORMAL BATTERY DEPLETION ONO OVERCONSUMPTION - THE EXPERTISE OF THE RETURNED ICD DIDN¿T REVEAL OVER-CONSUMPTION. - THE BATTERY ANALYSIS CONFIRMED THAT THE ROOT CAUSE OF THE FAST BATTERY DEPLETION IS A BATTERY FAILURE (DUE TO CLUSTER).

    Description of Event or Problem · 0

    REPORTEDLY, THE IMPLANT DEVICE CANNOT BE INTERROGATED. A DEVICE RESET OCCURRED AND THE ERI IS REACHED FOLLOWING A HIGH DECREASE OF THE BATTERY VOLTAGE. THE DEVICE IS EXPLANTED

    Description of Event or Problem · 0

    REPORTEDLY, THE IMPLANT DEVICE CANNOT BE INTERROGATED. A DEVICE RESET OCCURRED AND THE ERI IS REACHED FOLLOWING A HIGH DECREASE OF THE BATTERY VOLTAGE. THE DEVICE IS EXPLANTED.

    Description of Event or Problem · 0

    REPORTEDLY, THE IMPLANT DEVICE CANNOT BE INTERROGATED. A DEVICE RESET OCCURRED AND THE ERI IS REACHED FOLLOWING A HIGH DECREASE OF THE BATTERY VOLTAGE. THE DEVICE IS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270938 ULYS DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM MICROPORT CRM S.R.L. ULYS DF4 DR - 2540 08031527018492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention