BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS SR

    MDR report key: 1070905 · Received July 2, 2008

    Report

    Report Number
    1028232-2008-00722
    Event Type
    Injury
    Date Received
    July 2, 2008
    Date of Event
    December 27, 2007
    Report Date
    June 6, 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- VISUAL INSPECTION REVEALED LIGHT SCRATCHES ON THE FRONT SIDE OF THE PACEMAKER AND A SMALL AMOUNT OF DRIED BLOOD WAS FOUND IN THE LEAD PORTS. MECHANICAL INSPECTION OF THE CONNECTOR SYSTEM SHOWED NO DEVIATION FROM SPECIFICATION THAT MIGHT EXPLAIN ANY MALFUNCTION. THE SET SCREW COULD BE EASILY SCREWED IN AND OUT. CONTACT MARKS ON THE SET SCREW CONFIRMED A CONNECTION WITH A LEAD AT LEAST ONCE. ALSO, THE SPRING ELEMENT FOR THE ELECTRICAL CONTACT BETWEEN THE LEAD CONNECTOR AND THE PACEMAKER CHANNEL WAS IN SPECIFICATION. THE LEAD CONNECTED TO THE PACEMAKER DURING IMPLANTATION WAS NOT AVAILABLE FOR ANALYSIS. THEREFORE, AN ANALYSIS OF A SUFFICIENT CONNECTION BETWEEN THE INITIALLY IMPLANTED LEAD AND THE PACEMAKER COULD NOT BE PERFORMED. HOWEVER, A TEST LED COULD BE CONNECTED RELIABLY. UPON INCOMING INSPECTION THE PACEMAKER STIMULATED WITH THE FOLLOWING PARAMETERS: SSI-MODE/70 PPM. THE PACEMAKER WAS PROGRAMMED TO AN AMPLITUDE OF 6.0 V AND 0.4 MS PULSE WIDTH. THE PACEMAKER WAS SUBJECTED TO A COMPLETE FINAL ACCEPTANCE TEST AND PROVED TO BE WITHIN ALL ELECTRICAL SPECIFICATIONS. THE PULSE AMPLITUDE AND PULSE WIDTH FOUND TO BE SUFFICIENT. THE TESTING OF THE SENSITIVITY AND THE TIMING FUNCTIONS DID NOT REVEAL ANY DEVIATION FROM THE SPECIFICATION. IN SUMMARY, THERE WAS NO INDICATION OF SENSING AND/OR PACING PROBLEMS. THE DOCUMENTATION AS RECEIVED WAS ANALYZED. FOLLOW-UP DATA INCLUDING A PROGRAMMER PRINT OUT AND EXTERNAL ECGS WERE RECEIVED WITH THE PACEMAKER. IN 2007 (08:14H) THE PACING WAS PROGRAMMED TO 2.0 V AND 0.4 MS PULSE WIDTH. THE PULSE AMPLITUDE WAS LATER THAT DAY REPROGRAMMED TO 2.4 V WITH 0.4 MS PULSE WIDTH. THE THRESHOLD MEASUREMENT AT 8:20H CONFIRMED EFFECTIVE PACING WITH 0.7 V. AN INTRACARDIAL IEGM WAS PERFORMED AND 100 % PACING WITH AN RHYTHM OF 70 PPM WAS OBSERVED. AND 100% PACING WITH AN RHYTHM OF 70 PPM WAS OBSERVED. THE ANALYSIS OF THE EXTERNAL ECGS RECORDED IN THE AMBULANCE REVEALED AN HIGH FREQUENT STIMULATION RATE. THE ANALYSIS OF THE EXTERNAL ECGS RECORDED REVEALED A HIGH FREQUENT STIMULATION RATE. THE STIMULATION FREQUENCY WAS INCREASED MOST LIKELY DUE TO THE TRANSPORTATION. REGULAR STIMULATION SPIKES OBSERVED. HOWEVER, INTERMITTENTLY INEFFECTIVE PACING SPIKES WERE FOUND ON THE EXTERNAL ECG.

    Description of Event or Problem · 1

    OUS MDR. PT COLLAPSED AND BECAME UNCONSCIOUS. THIS WAS THE THIRD EPISODE OF THIS CLINICAL EVENT. FOLLOW-UP CHECK OF PACING SYSTEM IN HOSPITAL SHOWED NO ABNORMALITY, BUT THE AMBULANCE ECG SHOWED NON CAPTURE OF THE HEART. LEAD WAS A MEDTRONIC 4074. PRE-OP, DURING SURGERY AND POST REPLACEMENT SHOWED NORMAL TEST PARAMETERS AND OUTPUT BY THE PACEMAKER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS SR PACEMAKER DXY BIOTRONIK GMBH AND CO. 331446

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization