BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREVIA 5 HF-T QP DF4 IS4 PROMRI

    MDR report key: 11848942 · Received May 19, 2021

    Report

    Report Number
    1028232-2021-02715
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021. THE PREMATURE BATTERY DEPLETION COULD BE CONFIRMED DURING ANALYSIS.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF APPROX. 49 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747546 ITREVIA 5 HF-T QP DF4 IS4 PROMRI CRT-D NIK BIOTRONIK SE & CO. KG 402657

    Patients

    Seq Age Sex Outcome Treatment
    1