BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILIVIA 7 DR-T DF4 PROMRI

    MDR report key: 12781424 · Received November 9, 2021

    Report

    Report Number
    1028232-2021-06092
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 20, 2021
    Report Date
    October 28, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    UDI-DI
    04035479142100
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS ON THE RETURNED DEVICE DATA. THE RETURNED DEVICE DATA HAVE BEEN INSPECTED. THE BATTERY STATUS WAS FOUND TO BE EOS, DETECTED BY THE DEVICE ON OCTOBER 14, 2021. ANALYSIS OF THE SHOCK HOLTER DATA REVEALED THAT MULTIPLE CHARGING CYCLES WERE PERFORMED BY THE DEVICE AND RESULTED IN 52 SHOCK DELIVERIES BETWEEN OCTOBER 14, 2021 AT 10:11 AM AND OCTOBER 14, 2021 AT 10:41 AM. AS A RESULT OF THAT SUCCESSIVE CHARGING THE EOS BATTERY STATUS HAD OCCURRED. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED, REVEALING THAT THE BATTERY CONDITION IS AS EXPECTED. THE CURRENT CONSUMPTION WAS ALSO INSPECTED AND FOUND TO BE NORMAL. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. BASED ON THE DATA AVAILABLE FOR ANALYSIS NO FINAL CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. HOWEVER, SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 0

    THE ICD DELIVERED APPROXIMATELY 50 SHOCKS AND PRESENTED EOS. 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
    1682332 ILIVIA 7 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 404623 04035479142100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown