BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREVIA 7 VR-T DX DF-1 PROMRI

    MDR report key: 11874211 · Received May 25, 2021

    Report

    Report Number
    1028232-2021-02804
    Event Type
    Death
    Date Received
    May 25, 2021
    Date of Event
    May 13, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICD AND THE LEAD UNDER COMPLAINT WERE RETURNED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICES, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESSES FOR THESE DEVICES WERE RE-INVESTIGATED. ALL PRODUCTION STEPS WERE PERFORMED ACCORDINGLY, AND IN PARTICULAR THE FINAL ACCEPTANCE TESTS PROVED THE FUNCTIONS OF THE DEVICES TO BE AS SPECIFIED. PROTEGO DF-1 PROMRI S DX 65/15: UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE ANALYSIS REVEALED THAT IN ONE SECTION OF THE LEAD THE INSULATION WAS FOUND ABRADED THROUGH. THE ABRASION WAS CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION AGAINST THE GENERATOR HOUSING. FURTHERMORE, IN A SECOND SECTION OF THE LEAD, THE INSULATION WAS FOUND RUBBED THROUGH. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. SIGNIFICANT LEAD MOTION IN THE AREA OF THE TRICUSPID VALVE AND INTERACTION WITH ATYPICAL TISSUES SHOULD BE TAKEN INTO CONSIDERATION. THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. ITREVIA 7 VR-T DX DF-1 PROMRI: UPON RECEIPT, THE ICD INTERROGATION REVEALED THE EOS BATTERY STATUS, DETECTED BY THE DEVICE ON APRIL 25, 2021 AND 27 CHARGING CYCLES WERE RECORDED IN THE DEVICES MEMORY. THE DEVICE DATA WERE INSPECTED. THE INSPECTION OF THE FOLLOW-UP ARCHIVE REVEALED THAT THE DEVICE WAS IMPLANTED ON JULY 25, 2016. SINCE THEN, THE PATIENT WAS FOLLOWED UP REGULARLY AT APPROXIMATELY SIX-MONTH INTERVALS UNTIL MAY 19, 2019. AFTER THAT DATE NO FOLLOW-UP DATA WERE FOUND IN THE ARCHIVE. FURTHERMORE, THE DEVICE DATA SHOWED CONTINUOUSLY INCREASING CHARGING TIMES SINCE DECEMBER 16, 2019. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE INTERROGATED CURRENT CONSUMPTION OF THE ICD WAS FOUND TO BE NORMAL AND AS EXPECTED. HOWEVER, AN INCONSISTENCY BETWEEN THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY AND THE BATTERY VOLTAGE WAS NOTED. THEREFORE, THE DEVICE WAS OPENED AND THE INNER ASSEMBLY WAS INSPECTED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. THE OVERALL CURRENT CONSUMPTION OF THE ELECTRICAL MODULE WAS DIRECTLY MEASURED AND PROVED TO BE NORMAL AND AS EXPECTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE ELECTRONIC MODULE. THE BATTERY WAS SENT TO THE MANUFACTURER FOR A THOROUGH ANALYSIS. THE MANUFACTURING RECORDS OF THE BATTERY WERE INSPECTED, DOCUMENTING THAT THE BATTERY PARAMETERS WERE WITHIN SPECIFICATION DURING THE BATTERY MANUFACTURING. NO ANOMALIES WERE DOCUMENTED DURING THE PRODUCTION PROCESS, ASSOCIATED WITH THIS BATTERY. THE BATTERY WAS SUBJECTED TO A VISUAL INSPECTION WHICH DID NOT REVEAL ANY SIGNS OF DAMAGE. IN A NEXT STEP, THE BATTERY WAS OPENED FOR DESTRUCTIVE ANALYSIS. THE INSPECTION OF THE INNER ASSEMBLY IDENTIFIED LITHIUM PLATING, WHICH LED TO AN ELEVATED INTERNAL SELF-DEPLETION. IN CONCLUSION, THE INSULATION OF THE LEAD WAS FOUND ABRADED THROUGH IN TWO SECTIONS. HOWEVER, THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY SIGN OF MATERIAL OR MANUFACTURING PROBLEM. THE ICD ACTIVATED EOS BATTERY STATUS ON APRIL 25, 2021. THE DEVICE DATA SHOWED THAT THE LAST FOLLOW-UP WAS PERFORMED ON (B)(6) 2019. BASED ON THE ANALYSIS OF THE DEVICE THE ROOT CAUSE WAS IDENTIFIED TO BE AN INCREASED INTERNAL SELF-DEPLETION WITHIN THE BATTERY DUE TO LITHIUM PLATING. PLEASE NOTE, THIS ICD IS AFFECTED BY THE FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE WAS ADMITTED TO THE EMERGENCY UNIT AFTER RESUSCITATION. THE INTERROGATION OF THE DEVICES SHOWED EOS STATUS. LAST DEVICE FOLLOW-UP HAD BEEN PERFORMED ON (B)(6) 2019 AND SINCE THEN PATIENT WAS LOST FOR THE FOLLOW-UP. THE PATIENT DIED IN THE NIGHT OF (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777696 ITREVIA 7 VR-T DX DF-1 PROMRI ICD LWS BIOTRONIK SE & CO. KG 393036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death