BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPERIA 7 VR-T DF4 PROMRI

    MDR report key: 15001304 · Received July 13, 2022

    Report

    Report Number
    1028232-2022-03575
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    May 17, 2022
    Report Date
    July 7, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE DEVICE INTERROGATION REVEALED THE EOS BATTERY STATUS. AN AMOUNT OF 15 CHARGING CYCLES WAS 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 RIGHT VENTRICULAR AND FAR-FIELD CHANNELS OF EPISODE 43, RECORDED ON MAY 17TH, 2022. THE DATA FURTHER SHOWED THAT THE DEVICE AUTOMATICALLY ACTIVATED THE EOS BATTERY STATUS ON THE SAME DAY AT 13:48H. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF EPISODE 43 CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING. THE MRI MODE WAS NOT ACTIVATED ON MAY 17TH, 2022. IN A NEXT STEP, THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE EOS STATE WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE DEVICE STATUS MOS1. THE BATTERY VOLTAGE OF 3.10 V REVEALED A CHARGED BATTERY. 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. PARTICULARLY 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

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO EOS STATUS APPROXIMATELY 41 MONTHS AFTER THE IMPLANTATION. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668964 IPERIA 7 VR-T DF4 PROMRI ICD LWS BIOTRONIK SE & CO. KG 393030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization