BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II DR

    MDR report key: 3021807 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00793
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ITS RETURN, THE PACEMAKER UNDERWENT A VISUAL ANALYSIS. THE INSPECTION SHOWED SCRATCHES ON THE INSCRIBED SIDE OF THE HOUSING AND SMOKE TRACES, WHICH MIGHT BE CONNECTED TO ELECTRO-CAUTERY DURING THE EXPLANTATION. THE PACEMAKER UNDERWENT AN ELECTRICAL INCOMING GOODS INSPECTION. THE DEVICE WAS INTERROGATED AND SHOWED THE BATTERY STATUS 'ERI' SINCE (B)(6) 2013, PROBABLY DUE TO COLD TRANSPORTATION AND STORAGE CONDITIONS AFTER THE EXPLANTATION. THE BATTERY STATUS WAS SUCCESSFULLY RESET. THE MEMORY CONTENT OF THE PACEMAKER WAS ANALYZED. THE ANALYSIS OF THE MEMORY CONTENT SHOWED PROPER DEVICE BEHAVIOR. THE BATTERY WAS SUFFICIENTLY CHARGED. NEXT, THE IMPLANT'S CAPABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIAC OUTPUT SIGNAL MATCHED THE PROGRAMMED VALUES, AND THE SIGNAL SENSING OF THE DEVICE WAS OK. IN ADDITION, A LONG-TERM PACING TEST WAS PERFORMED. THE PACING FUNCTION DID NOT SHOW ANY ANOMALIES. THE DEVICE WAS ABLE TO PROVIDE THERAPY WITHOUT RESTRICTIONS. DURING ANALYSIS, A PACING THRESHOLD TEST WAS PERFORMED USING A HEART SIMULATOR. THE PACING THRESHOLD TEST FUNCTIONED PROPERLY. IN ADDITION, THE PROGRAMMING WAND WAS PLACED AND REMOVED SEVERAL TIMES. THE IMPLANT REACTED AS EXPECTED. IN PARTICULAR, IT WAS SHOWN THAT THE REED SWITCH FUNCTIONED PROPERLY. IN SUMMARY, THE DEVICE IS WITHIN SPECIFICATIONS IN REGARD TO THE ELECTRONICS. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE SPECIFICATION THAT COULD BE RELATED TO THE CLINICAL OBSERVATION. THERE WAS NO MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 8 MONTHS, IT WAS REPORTED THAT AN ASYSTOLE OCCURRED DURING AN ROUTINE PACEMAKER CHECK AFTER THE PROGRAMMING WAND WAS LIFTED. A BRIEF HEART MASSAGE WAS NECESSARY. THE DATE OF IMPLANT WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS DOING POORLY. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123686 PHILOS II DR PACEMAKER DXY BIOTRONIK SE & CO. KG 341826

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization