BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREVIA 5 DR-T DF4 PROMRI

    MDR report key: 14732536 · Received June 17, 2022

    Report

    Report Number
    1028232-2022-03127
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 10, 2022
    Report Date
    June 15, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE DEVICE INTERROGATION REVEALED THE EOS BATTERY STATUS, 27 CHARGING CYCLES WERE RECORDED IN THE DEVICES MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. DURING THE INSPECTION OF THE AVAILABLE IEGMS NOISE WAS OBSERVED IN THE ATRIAL, VENTRICULAR AND FAR-FIELD CHANNELS OF EPISODE 1064, RECORDED ON (B)(6) 2022 AT 14:55 H. THE DATA FURTHER SHOWED, THAT THE DEVICE AUTOMATICALLY ACTIVATED THE EOS BATTERY STATUS ON THE SAME DAY AT 14:55 H. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF EPISODE 1064 CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING. THE MRI MODE WAS NOT ACTIVATED ON (B)(6) 2022. IN A NEXT STEP, THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE DEVICE STATUS MOS2. THE BATTERY VOLTAGE OF 3.03 V REVEALED A CHARGED BATTERY. FOLLOWING, THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED, AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A NORMAL AND EXPECTED SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED, AND THE CHARGING TIME WAS AS EXPECTED. IN ADDITION, THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED AND ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. BASED ON THE ANALYSIS RESULTS, THE EOS STATUS MOST LIKELY RESULTED FROM THE REPORTED MRI SCAN WITHOUT PRIOR ACTIVATION OF THE MRI MODE. IF A CHARGING CYCLE OCCURS IN A STRONG EXTERNAL MAGNETIC FIELD, DEPENDING ON STRENGTH AND ORIENTATION, A SATURATION OF THE HIGH VOLTAGE TRANSFORMER MAY APPEAR, LEADING TO A TEMPORARY DROP OF THE SUPPLY VOLTAGE BELOW THE EOS LEVEL, RESULTING IN THE OBSERVED EOS BATTERY STATUS. THIS OBSERVATION DOES NOT REPRESENT A BATTERY OR HYBRID MALFUNCTION. THE ANALYSIS DID NOT REVEAL ANY INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    DEVICE IS AT EOS INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. BATTERY AT 30 PERCENT, BATTERY VOLTAGE 3.05V PRIOR TO MRI, DEVICE AT EOS AFTER MRI. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203199 ITREVIA 5 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown