BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREVIA 5 VR-T DX DF-1 PROMRI

    MDR report key: 15020012 · Received July 14, 2022

    Report

    Report Number
    1028232-2022-03618
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 12, 2022
    Report Date
    July 12, 2022
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS ON THE RETURNED DEVICE DATA. 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. THE RETURNED DEVICE DATA WAS INSPECTED. THE INSPECTION CONFIRMED THE EOS BATTERY STATUS. EOS WAS DETECTED ON (B)(6) 2022 AT 05:45 H. HOWEVER, THE BATTERY IS NOT DEPLETED. THE DATA FURTHER SHOWED A DETECTION OF STRONG MAGNETIC FIELDS AT 05:40 H, 5 MINUTES BEFORE THE EOS DETECTION. THE MRI MODE WAS NOT ACTIVATED. THE ANALYSIS OF THE AVAILABLE IEGMS FROM EPISODE NR. 9 FROM (B)(6) 2022 AT 05:43 H SHOWED NOISE IN ALL CHANNELS. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF EPISODE NR. 9 CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING (MRI), WHICH IS CONSISTENT WITH THE ABOVE OBSERVATIONS. IN GENERAL, 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. IT IS THEREFORE ASSUMED THAT A PROCEDURE CONTAINING STRONG MAGNETIC FIELDS, SUCH AS AN MRI SCAN, MIGHT HAVE LED TO THE CLINICAL OBSERVATION. PLEASE NOTE, UPON MRI SCAN WITHOUT PREPROGRAMMING THE DEVICE IN MRI MODE, SUBSEQUENT DAMAGES TO THE ELECTRONIC MODULE CANNOT BE FULLY EXCLUDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS IN EOS STATUS (BATTERY DEPLETION) APPROX. 65 MONTHS AFTER THE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464438 ITREVIA 5 VR-T DX DF-1 PROMRI ICD LWS BIOTRONIK SE & CO. KG 393054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown