BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPERIA 7 HF-T QP DF4 IS4 PROMRI

    MDR report key: 14079365 · Received April 11, 2022

    Report

    Report Number
    1028232-2022-01850
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 7, 2022
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    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 BATTERY STATUS EOS, 32 CHARGING CYCLES WERE RECORDED TO THE DEVICE 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 CHANNEL OF EPISODE 28, RECORDED ON APRIL 04, 2022. THE DATA FURTHER SHOWED, THAT THE DEVICE AUTOMATICALLY ACTIVATED THE BATTERY STATUS EOS ON THE SAME DAY AT 13:27 PM. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF EPISODE 28 CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING. THE MRI MODE WAS NOT ACTIVATED ON APRIL 04. THE EOS STATE WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE DEVICE STATUS MOS2. THE BATTERY VOLTAGE OF 2.84 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 CORRECT 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. ALL PRODUCTION STEPS HAD BEEN 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 A 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 BATTERY STATUS EOS. 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

    AFTER AN IMPLANTATION PERIOD OF APPROX. 81 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE EOS STATUS. THE ICD WAS EXPLANTED. 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
    192230 IPERIA 7 HF-T QP DF4 IS4 PROMRI NIK BIOTRONIK SE & CO. KG 401657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization