BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFORIA 3 DR-T DF-1

    MDR report key: 11760332 · Received May 3, 2021

    Report

    Report Number
    1028232-2021-02196
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS OF THIS ICD WERE REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. A PERFORMED STANDARD FINAL ELECTRICAL TEST DOCUMENTED PROPER DEVICE BEHAVIOR. SUBSEQUENTLY, THE ICD UNDERWENT A STATUS INTERROGATION WITH A CLINICAL PROGRAMMER, AND THE DEVICE MEMORY WAS ANALYZED. MATCHING THE CLINICAL OBSERVATION, THE ICD SHOWED THE DEVICE STATUS ERI. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED, REVEALING AN INCONSISTENCY BETWEEN DRAWN CHARGE AND MEASURED BATTERY VOLTAGE. PREMATURE BATTERY DEPLETION WAS CONFIRMED DURING THE ANALYSIS. THIS DEVICE IS AFFECTED BY THE CORRECTIVE SAFETY MEASURE IN THE FIELD, BIO-LOQ, THAT WAS COMMUNICATED IN MARCH 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED APPROX. 34 MONTHS AFTER THE IMPLANTATION DUE TO ERI STATUS. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656254 IFORIA 3 DR-T DF-1 ICD MRM BIOTRONIK SE & CO. KG 383570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization