BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILOS II DR

    MDR report key: 2973479 · Received February 16, 2013

    Report

    Report Number
    1028232-2013-00292
    Event Type
    Death
    Date Received
    February 16, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. 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 SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    PT WENT INTO VF, TAKEN TO HOSPITAL. EXTERNAL SHOCK WAS GIVEN MULTIPLE TIMES, WITH A PAD PLACED RIGHT OVER THE DEVICE. PT HAS ALSO BEEN UNDERGOING CANCER THERAPY OF UNKNOWN FORM. LAST DEVICE CHECK WAS DONE IN JANUARY; EVERYTHING WAS NOMINAL WITH PT AND DEVICE. UPON SHOCK, DEVICE NO LONGER CAPTURED IN THE RV, AND UNDER-SENSING WAS FOUND. PT IS UNABLE TO BREATH ON OWN, STILL IN HOSPITAL AT THIS TIME. DEVICE REMAINS IMPLANTED. LEAD WAS SWITCHED FROM BIPOLAR TO UNIPOLAR AND CAPTURE AND SENSING RETURNED. ON (B)(6) 2013 - WE WERE INFORMED THIS PT EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69957 PHILOS II DR PACEMAKER DTB BIOTRONIK SE & CO. KG 341826

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization