BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFORIA 7 VR-T DX PROMRI DF-1

    MDR report key: 9735074 · Received February 20, 2020

    Report

    Report Number
    1028232-2020-00831
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 17, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EXPLANTED ON (B)(6) 2020 DUE TO EOS. UPON RECEIPT, THE DEVICE INTERROGATION REVEALED THE EOS BATTERY STATUS, CONFIRMING THE CLINICAL OBSERVATION. THE EOS STATE WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE DEVICE STATUS BOS. THE BATTERY VOLTAGE OF 3.07V REVEALED A CHARGED BATTERY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. ONE EPISODE WAS RECORDED BY THE DEVICE ON (B)(6) 2018 AT 11:31AM, WHICH, HOWEVER, WAS NOT SAVED TO THE EPISODE HOLTER AS A RESULT OF THE EOS ACTIVATION DURING THIS EPISODE. DURING INSPECTION OF THE CORRESPONDING IEGM NOISE WAS OBSERVED IN THE ATRIAL, VENTRICULAR AND FAR-FIELD CHANNEL. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF THE EPISODE 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) 2018. IN A NEXT STEP, THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. FIRST, A SENSING TEST WAS PERFORMED. THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTIONS OF THE ICD TO BE NORMAL. 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. 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 AN 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. THOROUGH ANALYSIS OF THE DEVICE DID NOT REVEAL ANY INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EXPLANTED ON (B)(6) 2020 DUE TO EOS.-

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EOS WAS DETECTED ON THIS DEVICE ON (B)(6) 2018. NO SHOCK WAS DELIVERED AND THERE WAS NO APPARENT CAUSE FOR SUDDEN BATTERY DRAIN. THE EVENT WAS DETECTED ON (B)(6) 2020, THE DEVICE WAS NOT INTERROGATED IN 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197485 IFORIA 7 VR-T DX PROMRI DF-1 ICD LWS BIOTRONIK SE & CO. KG 390095

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization