BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPERIA 7 DR-T DF4 PROMRI

    MDR report key: 7918760 · Received September 28, 2018

    Report

    Report Number
    1028232-2018-03348
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    July 11, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE DEVICE COULD BE INTERROGATED BY A CLINICAL PROGRAMMER, REVEALING THE BATTERY STATUS EOS. EIGHT CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE INSPECTION REVEALED THAT THE MAGNET RESONANCE SENSORS OF THE ICD DETECTED STRONG ELECTROMAGNETIC FIELDS ON (B)(6) 2018, WHICH INDICATES THE BEGINNING OF THE REPORTED MAGNETIC RESONANCE IMAGING. AT THIS DATE THE MRI MODE OF THE ICD WAS NOT ACTIVATED. FURTHERMORE THE AVAILABLE IEGMS OF (B)(6) 2018 SHOWED EXTERNAL INTERFERING SIGNALS IN ALL CHANNELS. THE FREQUENCY AND MORPHOLOGY OF THE SENSED INTERFERING SIGNALS AS WELL AS THE EOS DETECTION CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS, LIKELY DUE TO THE REPORTED MRI SCAN. THEREFORE A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE. THE EOS STATUS COULD BE REMOVED BY A TECHNICAL PROGRAMMER AND THE DEVICE SHOWED THE BOS STATUS UPON INTERROGATION. THE BATTERY VOLTAGE OF 3.09 V REVEALED A CHARGED BATTERY. AFTERWARDS, 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. IN CONCLUSION, THE INTERROGATION OF THE ICD WAS SUCCESSFULLY PERFORMED BY A CLINICAL PROGRAMMER, REVEALING THE BATTERY STATUS EOS. AFTER REPROGRAMMING THE DEVICE WITH A TECHNICAL PROGRAMMER THE DEVICE SHOWED THE BOS STATUS WITH A NORMALLY CHARGED BATTERY. BESIDES THIS, THE DEVICE WAS PROVEN TO BE FULLY FUNCTIONAL. THE OBSERVED DEVICE BEHAVIOR WAS MOST PROBABLY CAUSED BY A STRONG EXTERNAL MAGMATIC FIELD DURING THE REPORTED MAGNETIC RESONANCE IMAGING. THE MRI MODE OF THE ICD WAS NOT ACTIVATED AT THAT TIME. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT 23 MONTHS AFTER THE IMPLANT THE DEVICE WAS EXPLANTED DUE TO EOS AFTER THE PATIENT UNDERWENT MRI PROCEDURE TWICE WITHOUT THE ACTIVATION OF THE MRI MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760563 IPERIA 7 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392423

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization