BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II S COATED

    MDR report key: 1181898 · Received September 25, 2008

    Report

    Report Number
    1028232-2008-01134
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    April 16, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR: UPON RECEIPT, THE PACEMAKER WAS SUBJECTED TO A VISUAL AND MECHANICAL INSPECTION. THE MECHANICAL INSPECTION OF THE CONNECTOR SYSTEM SHOWED NO DEVIATION FROM THE SPECIFICATION THAT MIGHT EXPLAIN AND MALFUNCTION. ALL DIMENSIONS OF THE HEADER BORE WERE WITHIN IS-1 STANDARD SPECIFICATIONS. THE SET SCREW WAS EFFECTIVELY CONTACTING THE CONNECTOR PINS. THE SET SCREW COULD BE EASILY SCREWED IN AND OUT. ALSO, THE SPRING ELEMENT FOR THE ELECTRICAL CONTACT BETWEEN THE LEAD CONNECTOR AND THE PACEMAKER CHANNEL DID NOT SHOW DEVIATIONS. A SAMPLE LEAD CONNECTOR COULD BE INSERTED AND CONNECTED EASILY TO THE DEVICE. UPON INCOMING INSPECTION THE PACEMAKER STIMULATED WITH THE FOLLOWING PARAMETERS: VVI: MODE/80PPM/3.6V/0.4MS/BIPOLAR. THE SENSITIVITY WAS PROGRAMMED TO 1.0MV. THE PACEMAKER WAS SUBJECTED TO A COMPLETE FINAL ACCEPTANCE TEST AND PROVED TO BE WITHIN ALL ELECTRICAL SPECIFICATIONS. THERE WAS NO INDICATION OF SENSING AND/OR PACING PROBLEMS. THE PACEMAKER PROBED TO BE FULLY FUNCTIONAL. NO DOCUMENTATION WAS RETURNED CONFIRMING LOSS OF PACING OR LOSS OF CAPTURE. IN SUMMARY, THIS PACEMAKER DID NOT SHOW ANY SIGN OF MATERIAL OR MANUFACTURING PROBLEM. IT IS COMPLETELY WITHIN ITS SPECIFICATIONS. THE PACEMAKER WS NOT THE ROOT CAUSE FOR THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    OUS MDR: ONE DAY POST IMPLANTATION, IT WAS REPORTED THAT THE PACEMAKER WAS NOT PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS II S COATED PACEMAKER DXY BIOTRONIK GMBH AND CO., 341819

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization