BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS D

    MDR report key: 4101325 · Received September 19, 2014

    Report

    Report Number
    1028232-2014-003300
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 11, 2014
    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

    UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED REVEALING NO ANOMALIES. IN PARTICULAR THE HEADER OF THE DEVICE WAS ANALYZED. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT, THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORES. ALL DIMENSIONS OF THE HEADER BORES WERE WITHIN THE RANGE REQUESTED BY THE IS-1 STANDARD SPECIFICATIONS. ALSO THE SPRING ELEMENTS OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. NEXT, THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED INDICATING NO ANOMALIES. THE BATTERY STATUS WAS FOUND TO BE "OK" AFTER AN IMPLANTATION DURATION OF 62 MONTHS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. AN ADDITIONAL LONG-TERM PACING TEST WAS INITIATED. DURING THE TEST, EACH PACING PULSE WAS RECORDED. THE EVALUATION OF THESE PACING PULSES DOCUMENTED REGULAR DEVICE BEHAVIOR. NO INTERMITTENT OR PERMANENT LOSS OF OUTPUT WAS PRESENT. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE ER BECAUSE HIS WIFE FOUND IT QUITE DIFFICULT TO WAKE HIM AND WHEN HE DID WAKE, HE WAS CONFUSED. HIS HEART RATE WAS 20-30 BPM. THE DEVICE WAS INTERROGATED BY HOSPITAL STAFF. IT WAS PROGRAMMED VDD 80. ALL MEASUREMENTS SUCH AS THRESHOLD, IMPEDANCE, SENSING VALUES WERE NORMAL. THIS DEVICE WAS EXPLANTED AND REPLACED WITH AN OEM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581848 PHILOS D PACEMAKER DXY BIOTRONIK SE & CO. KG 122447

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization