BEUDAMED
    FDA Adverse Event Death Summary report: N

    IFORIA 7 VR-T DX PROMRI DF-1

    MDR report key: 6067866 · Received October 31, 2016

    Report

    Report Number
    1028232-2016-04127
    Event Type
    Death
    Date Received
    October 31, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 12, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    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 THE RETURNED DEVICE DATA. THE RETURNED DEVICE DATA HAVE BEEN ANALYZED. THE ANALYSIS DID NOT SHOW ANY ANOMALIES. 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 REVEALED NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING IMPLANTED TO TREAT SEVERE VT, VF AND HF. DURING THE IMPLANT AND DIRECTLY AFTER, ALL PARAMETERS WERE NORMAL. HOWEVER, THE PATIENT WAS FOUND UNCONSCIOUS. THE PHYSICIAN RESCUED THE PATIENT AND TRANSFERRED HIM TO ICU. HOWEVER, THE PATIENT EXPIRED THE SAME DAY. THE DEVICE DETECTED ONCE VT AND TREATED IT SUCCESSFULLY. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718810 IFORIA 7 VR-T DX PROMRI DF-1 ICD LWS BIOTRONIK SE & CO. KG 390095

    Patients

    Seq Age Sex Outcome Treatment
    1 Death