BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILIVIA 7 HF-T QP DF4 IS4 PROMRI

    MDR report key: 12127165 · Received July 7, 2021

    Report

    Report Number
    1028232-2021-03746
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 1, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    UDI-DI
    04035479142087
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    DEVICE COULD NOT BE INTERROGATED IN EMERGENCY ROOM. HARD REBOOT, VARIOUS PGH POSITIONS, FORCED INTERROGATION WERE NOT SUCCESSFUL. WHEN PGH PLACED OVER THE DEVICE, A GREEN LIGHT WOULD FLASH AND THE PROGRAMMER SCREEN WOULD FREEZE. EMI CANNOT BE RULED OUT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025214 ILIVIA 7 HF-T QP DF4 IS4 PROMRI CRT-D NIK BIOTRONIK SE & CO. KG 404621 04035479142087

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR