BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREVIA 7 DR-T DF-1

    MDR report key: 10368113 · Received August 5, 2020

    Report

    Report Number
    1028232-2020-03118
    Event Type
    Death
    Date Received
    August 5, 2020
    Date of Event
    July 23, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    UDI-DI
    04035479128807
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE ONLY BASED ON THE RETURNED DEVICE DATA AS WELL AS THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. 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. IN A NEXT STEP, THE RETURNED DEVICE DATA WAS INSPECTED. DURING THE INSPECTION THE CLINICAL OBSERVATION COULD BE CONFIRMED. FURTHER ANALYSIS REVEALED AN UNEXPECTED BATTERY BEHAVIOR, WHICH LED TO THE CLINICAL OBSERVATION. BASED ON THE DATA AVAILABLE FOR ANALYSIS THE ROOT CAUSE FOR THAT BEHAVIOR WAS NOT DETERMINABLE AND CAN ONLY BE CLARIFIED BY AN ANALYSIS OF THE DEVICE ITSELF. HOWEVER, IT CANNOT BE EXCLUDED THAT THIS OCCURRENCE RESULTED FROM A DAMAGED COMPONENT, WHICH MAY COMPROMISE THE ABILITY OF THE DEVICE TO DELIVER THERAPY. BIOTRONIK HAS INFORMED THE HEALTH CARE PROFESSIONAL ABOUT THIS ANALYSIS RESULT, WHO DECIDES, BASED ON THE PATIENTS INDIVIDUAL CIRCUMSTANCES AND MEDICAL JUDGMENT, IF THE DEVICE WILL BE EXCHANGED. SHOULD FURTHER RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED AND YOU WILL BE INFORMED ACCORDINGLY. SHOULD FURTHER RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    DEVICE REACHED ERI ON (B)(6) 2020 AFTER RECORDING 35 PERCENT BATTERY ON THE PREVIOUS DAY. DEVICE REACHED EOS ON (B)(6) 2020. PATIENT PASSED AWAY ON (B)(6) 2020, CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834616 ITREVIA 7 DR-T DF-1 ICD MRM BIOTRONIK SE & CO. KG 392412 04035479128807

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death