BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDIS

    MDR report key: 18578133 · Received January 25, 2024

    Report

    Report Number
    1000165971-2024-00071
    Event Type
    Death
    Date Received
    January 25, 2024
    Date of Event
    November 15, 2023
    Report Date
    January 25, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. INVESTIGATION RESULT: THE EDIS DF4 CRT-D WAS IMPLANTED ON (B)(6) 2022. ANALYSIS OF THE PROVIDED PATIENT FILES DATED FROM ON (B)(6) 2022 (IMPLANTATION DATE) TO ON (B)(6) 2023 (LAST FOLLOW-UP PERFORMED) CONFIRMED THE NORMAL DEVICE FUNCTIONING. REVIEW OF THE LAST PATIENT FILES (DATED ON (B)(6) 2023) PROVIDED LED TO THE FOLLOWING OBSERVATIONS: BATTERY STATUS WAS STILL WITHIN NORMAL RANGE (3.13V) RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS REMAINED STABLE AND WITHIN THE NORMAL RANGE (474 OHMS) - RV COIL CONTINUITY MEASUREMENTS REMAINED STABLE AND WITHIN NORMAL RANGE (376 OHMS) - NO ABNORMAL EPISODES WERE RECORDED SINCE THE IMPLANTATION. REVIEW OF MANUFACTURING RECORD REVEALED THAT THE DEVICE WAS MANUFACTURED AND RELEASED ACCORDING FOLLOWING ALL APPLICABLE PROCEDURES. AS THE SUSPECTED DEVICE WAS NOT RETURNED SINCE IT REMAINS IMPLANTED AND NO PATIENT FILES WERE AVAILABLE FOR THE TIME PERIOD SURROUNDING THE PATIENT¿S DEATH, NO FURTHER INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 0

    REPORTEDLY, A PATIENT INCLUDED IN APOLLO STUDY IMPLANTED FOR A SECONDARY PREVENTION ON (B)(6) 2023. THE LAST HOSPITAL VISIT WAS DONE ON (B)(6) 2023. ON (B)(6) 2023, THE HOSPITAL WAS INFORMED THAT PATIENT DIED WITH UNDERMINED CAUSE. THERE IS NO RELATION BETWEEN THE DEATH AND THE IMPLANTATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475845 EDIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MICROPORT CRM S.R.L. EDIS DF4 VR - 2140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown