BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFORIA 5 VR-T DX PROMRI DF-1

    MDR report key: 10639143 · Received October 6, 2020

    Report

    Report Number
    1028232-2020-04284
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 10, 2020
    Report Date
    September 10, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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, WHICH SHOWED AN INCONSISTENCY BETWEEN DRAWN CHARGE AND MEASURED BATTERY VOLTAGE. PREMATURE BATTERY DEPLETION COULD BE CONFIRMED DURING THE ANALYSIS. THIS DEVICE IS AFFECTED BY THE SAFETY CORRECTIVE MEASURE IN THE FIELD, BIO-LOQ, COMMUNICATED IN (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS AND THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS OF THIS DEVICE WAS 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. THE RETURNED DEVICE DATA WERE ANALYZED. THE DEVICE STATUS ERI WAS CONFIRMED. THE BATTERY VOLTAGE WAS THEN CHECKED IN REGARD TO THE CHARGE DRAWN FROM THE BATTERY, WHICH TURNED OUT NOT TO BE AS EXPECTED. BIOTRONIK HAS INFORMED THE PHYSICIAN ABOUT THIS ANALYSIS RESULT, WHO WILL DECIDE BASED ON THE INDIVIDUAL CIRCUMSTANCES AND THE MEDICAL EVALUATION OF THE PATIENT WHETHER THE DEVICE WILL BE EXCHANGED. IF ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF SHOULD BECOME AVAILABLE, THIS REPORT WILL BE UPDATED, AND YOU WILL BE INFORMED ACCORDINGLY.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF APPROX. 58 MONTHS, THE ERI STATUS WAS OBSERVED VIA HOME MONITORING. THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099273 IFORIA 5 VR-T DX PROMRI DF-1 ICD LWS BIOTRONIK SE & CO. KG 390123

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization