BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFORIA 3 VR-T DF-1

    MDR report key: 4110011 · Received September 23, 2014

    Report

    Report Number
    1028232-2014-003389
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER IT WAS RECEIVED, THE ICD WAS FIRST VISUALLY INSPECTED. THE SPARKOVER TRACES ON THE ICD HOUSING WERE NOTED IN THE PROCESS. THE DOT-SHAPED SITE OF LOCALLY MOLTEN TITANIUM INDICATES A SPARKOVER DURING A SHOCK DELIVERY BETWEEN THE HOUSING AND THE HV-1 CONDUCTOR OF THE LEAD. THIS IS NOT A DEVICE MALFUNCTION OF THE ICD. THERE WAS NO MATERIAL DEFECT OR MANUFACTURING ERROR. IN AGREEMENT WITH THE CLINICAL OBSERVATION, INTERROGATION OF THE ICD WAS NOT POSSIBLE. THEREFORE, THE ICD HOUSING WAS OPENED IN A NEXT STEP, AND THE INTERNAL STRUCTURE WAS EXAMINED. DURING THE INSPECTION OF THE ELECTRICAL MODULE, DAMAGE TO THE FINAL SHOCK STAGES AND A TRIGGERED ELECTRICAL FUSE COULD BE DETECTED. THIS DAMAGE INDICATES A SHOCK DELIVERY INTO AN EXTERNAL LOW-OHMIC SHOCK PATH, MATCHING THE SPARKOVER TRACES ON THE HOUSING. THE TRIGGERING OF THE FUSE LED TO A SEPARATION OF THE BATTERY AND THE ELECTRONIC MODULE, WITH THE RESULT THAT THE DEVICE COULD NOT BE INTERROGATED. THIS DAMAGE MANIFESTATION INDICATES A DAMAGED LEAD INSULATION IN THE REGION OF THE ICD POCKET, WHICH IS CONFIRMED BY THE CLINICAL OBSERVATION REGARDING THE LEAD. THE LEAD COMPLAINED ABOUT WAS NOT AVAILABLE FOR ANALYSIS. IN SUMMARY, THE ANALYSIS OF THE ICD SHOWED DAMAGE TO THE FINAL SHOCK STAGE DUE TO A SHOCK DELIVERY INTO AN EXTERNAL LOW-OHMIC SHOCK PATH. DISCOVERED SPARKOVER TRACES ON THE ICD HOUSING INDICATE A DAMAGED LEAD INSULATION. THE LEAD COMPLAINED ABOUT WAS, HOWEVER, NOT AVAILABLE FOR ANALYSIS. THE DAMAGE TO THE FINAL SHOCK STAGE RESULTED IN TRIGGERING THE ELECTRICAL FUSE, WHICH LED TO THE CLINICAL OBSERVATION. THIS IS NOT A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 14 WEEKS, IT WAS REPORTED THAT THE ICD SHOCKED ADEQUATELY IN (B)(6) 2014 DUE TO VENTRICULAR FIBRILLATION. IT WAS ALSO REPORTED THAT A SCHEDULED FOLLOW-UP WAS PERFORMED ON (B)(6) 2014, DURING WHICH THE ICD COULD NO LONGER BE INTERROGATED. DURING THE EXPLANTATION OF THE ICD ON (B)(6) 2014, SUSPECTED INSULATION DAMAGE WAS OBSERVED ABOUT 2 CM BEHIND THE CONNECTOR. THE LEAD WAS CAPPED AND REMAINS INSIDE THE PATIENT. THE ICD WAS RETURNED TO BIOTRONIK FOR ANALYSIS. NO WORSENING OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589699 IFORIA 3 VR-T DF-1 ICD LWS BIOTRONIK SE & CO. KG 383586

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization