BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREVIA 5 DR-T DF4 PROMRI

    MDR report key: 7184145 · Received January 11, 2018

    Report

    Report Number
    1028232-2018-00094
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 27, 2017
    Report Date
    January 4, 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

    Narratives

    Additional Manufacturer Narrative · 1

    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 RETURNED DEVICE DATA HAVE BEEN ANALYZED. THE ANALYSIS OF THE AVAILABLE DEVICE DATA CONFIRMED THE CLINICAL OBSERVATION, THE BATTERY STATUS EOS HAD BEEN TRIGGERED ON (B)(6) 2017. HOWEVER, THE BATTERY IS DEFINITELY NOT DEPLETED. THE ANALYSIS OF THE AVAILABLE IEGMS SHOWED NOISE IN ALL CHANNELS. THE FREQUENCY AND MORPHOLOGY OF THE SENSED SIGNALS OF EPISODE 1 CAN BE MOST PROBABLY ATTRIBUTED TO STRONG EXTERNAL ELECTROMAGNETIC FIELDS AS USED BY MAGNETIC RESONANCE IMAGING. AS REPORTED, THE PATIENT UNDERWENT AN MRI SCAN. THE MRI MODE WAS NOT ACTIVATED ON (B)(6) 2017. 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 BATTERY STATUS EOS. THIS OBSERVATION DOES NOT REPRESENT A BATTERY OR HYBRID MALFUNCTION. 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 WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN CONCLUSION, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. THE ANALYSIS OF THE RETURNED DEVICE DATA SHOWED THAT THE CLINICAL OBSERVATION MOST LIKELY RESULTED FROM THE REPORTED MRI SCAN WITHOUT A PRIOR ACTIVATION OF THE MRI MODE.

    Description of Event or Problem · 1

    OUS MDR - PATIENT UNDERWENT AN MRI SCAN ON (B)(6) 2017 WITHOUT INFORMING HIS CARDIOLOGIST AND BIOTRONIK TEAM. EOS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28164 ITREVIA 5 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392421

    Patients

    Seq Age Sex Outcome Treatment
    1