BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILESTO 7 VR-T DX PROMRI DF-1

    MDR report key: 7729146 · Received July 27, 2018

    Report

    Report Number
    1028232-2018-02667
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 20, 2018
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ICD WAS INTERROGATED, REVEALING THE BATTERY STATUS EOS. THE ICD WAS IMPLANTED FOR ABOUT 44 MONTHS AND 17 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS ANALYZED. DURING ANALYSIS OF THE AVAILABLE IEGMS NOISE WAS OBSERVED IN THE RIGHT ATRIAL, RIGHT VENTRICULAR AS WELL AS THE FAR FIELD CHANNEL OF EPISODES 145 TO 147, LEADING TO TWO CHARGING CYCLES IN EPISODE 147. ONE CHARGING CYCLE OF EPISODE 147 WAS ABORTED DUE TO THE ACTIVATION OF THE BATTERY STATUS EOS ON (B)(6) 2018 AT 01:25 PM. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING (MRI). AT A NEXT STEP, THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THEREFORE THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION REVEALED THE BATTERY STATUS MOS1. 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. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. 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. 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 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 · 1

    OUS MDR. ON (B)(6) 2018 AN MRI WAS PERFORMED WITHOUT PREVIOUS REPROGRAMMING. THE DEVICE INDICATED PREMATURE EOS AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568837 ILESTO 7 VR-T DX PROMRI DF-1 ICD LWS BIOTRONIK SE & CO. KG 390094

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization