BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREVIA 5 DR-T DF4 PROMRI

    MDR report key: 12158405 · Received July 13, 2021

    Report

    Report Number
    1028232-2021-03899
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 5, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    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 (B)(6) 2021. THE PREMATURE BATTERY DEPLETION COULD BE CONFIRMED DURING ANALYSIS.

    Description of Event or Problem · 1

    THE ICD BELONGS TO THE LQC GROUP. PREMATTURE BATTERY DEPLETION. DEVICE REPLACED. 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
    1055871 ITREVIA 5 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392421

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization