BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS II DR-T

    MDR report key: 3002104 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00645
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    November 21, 2012
    Report Date
    February 28, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ITS RETURN, THE PACEMAKER UNDERWENT AN ELECTRICAL INCOMING GOODS INSPECTION. THE PACEMAKER WAS INTERROGATED, AND THE MEMORY CONTENT WAS ANALYZED. THE PACEMAKER SWITCHED TO THE BATTERY STATUS "ERI" ON THE DAY OF THE EXPLANTATION DUE TO COLD TRANSPORT OR STORAGE CONDITIONS. THE BATTERY STATUS "ERI" WAS RESET SUCCESSFULLY. AFTER THAT, THE DEVICE'S CAPABILITY TO DELIVER THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL MATCHED THE PROGRAMMED VALUES, AND THE SIGNAL SENSING OF THE DEVICE WAS NORMAL. THE PACEMAKER SHOWED BEHAVIOR ACCORDING TO SPECIFICATIONS IN REGARD TO ITS DEVICE FUNCTIONS. NEXT, THE MEMORY EXCERPT OF THE PROGRAMMER WAS ANALYZED. THE DATA DOCUMENT THAT A RE-INITIALIZATION TOOK PLACE. AFTER RE-INITIALIZATION, A BET IS ONLY POSSIBLE IF THE PROGRAMMING WAND IS REMOVED FOR A FEW SECONDS. THE PERFORMANCE OF A BET WAS POSSIBLE WITHOUT PROBLEMS DURING THE ANALYSIS. IN SUMMARY, THE IMPLANT PROVED TO BE WITHIN THE ELECTRICAL SPECIFICATIONS. A BET DURING THE ANALYSIS WAS SUCCESSFUL. THERE WERE NO INDICATIONS OF A MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - DURING INTERROGATION, THE DEVICE NEEDED TO BE RE-INITIALIZED, WHICH WAS PERFORMED SUCCESSFULLY. DESPITE THE EVENT DESCRIPTION SUGGESTING THIS DEVICE REMAINS IMPLANTED, IT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104839 PHILOS II DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 343175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization