BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II DR

    MDR report key: 3193448 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01782
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 13, 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

    THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE FLAWLESS. UPON RECEIPT, THE DEVICE WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. AN INITIAL INTERROGATION WAS PROPERLY FEASIBLE. THE BATTERY STATUS WAS FOUND TO BE ¿OK¿. THE PACEMAKER¿S MEMORY CONTENT WAS ANALYZED CONFIRMING THE CLINICAL OBSERVATION. THE PACEMAKER SWITCHED TO THE BATTERY STATUS ¿ERI¿ ON MAY 01, 2013 AS A RESULT OF THE MEASUREMENT OF A HIGH BATTERY IMPEDANCE RESULTING PER DESIGN TO A SWITCH INTO THE BATTERY STATUS ¿ERI¿. HOWEVER, THE DEVICE WAS PROGRAMMED OUT OF THE ¿ERI¿ MODE BEFORE THE DEVICE WAS RETURNED BY REPROGRAMMING. FURTHER ANALYSIS DID NOT REVEAL ANY ANOMALIES. 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. IN THE FOLLOWING THE PACEMAKER WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. SUBSEQUENT INVESTIGATIONS SHOWED THAT THE BATTERY WAS PARTLY DEPLETED BUT STILL SUFFICIENTLY CHARGED. THE ANALYSIS OF THE CURRENT CONSUMPTION SHOWED EXPECTED VALUES. THE MEASURED BATTERY IMPEDANCE AMOUNTED TO 830 OHMS CONSISTENT WITH THE USED BATTERY CAPACITY DOCUMENTED IN THE PACEMAKER¿S MEMORY CONTENT. DURING THE FURTHER COURSE OF THE ANALYSIS BOTH THE BATTERY AND THE ELECTRONIC MODULE WERE SENT TO MANUFACTURER FOR A DETAILED ROOT CAUSE ANALYSIS. DURING THE ANALYSIS OF THE BATTERY, THE MANUFACTURING RECORDS WERE INSPECTED, DOCUMENTING THAT THE BATTERY PARAMETERS WERE WITHIN SPECIFICATION DURING THE BATTERY MANUFACTURING. NO DEVIATIONS WERE DOCUMENTED DURING THE PRODUCTION PROCESS, ASSOCIATED TO THIS BATTERY. THE VISUAL INSPECTION OF THE BATTERY DID NOT REVEAL ANY EXTERNAL SIGNS OF DAMAGE. THE VOLTAGE MEASUREMENT CONFIRMED THE PARTLY DEPLETED BATTERY. NO ANOMALIES WERE NOTED DURING THE BATTERY ANALYSIS. THE BATTERY WAS FOUND TO BE WITHIN SPECIFICATION. THE ELECTRONIC MODULE WAS THOROUGHLY INSPECTED. THE VISUAL INSPECTION OF THE ELECTRONIC MODULE REVEALED NO ANOMALIES. HOWEVER, DURING THE COMPONENT ANALYSIS IT WAS NOTICED THAT THE PACEMAKER MEASURED AN IMPEDANCE HIGHER THAN THE TRUE BATTERY IMPEDANCE RESULTING IN A SHORTER CALCULATED TIME TO ERI LEADING TO THE CLINICAL OBSERVATION. IN SUMMARY, THE SHORTENING OF THE TIME TO ERI RESULTED FROM A HIGHER MEASURED BATTERY IMPEDANCE. HOWEVER, THE THERAPY FUNCTIONALITY OF THE PACEMAKER WAS NOT COMPROMISED AND THE TOTAL SERVICE TIME OF THE PACEMAKER WAS NOT AFFECTED.

    Description of Event or Problem · 1

    OUS MDR - THIS DEVICE WAS IMPLANTED SOMETIME IN 2010. IT IS NOW REPORTING ERI, BUT THE BATTERY VOLTAGE IS STILL 2.69 V AND IMPDEDANCE 2.6 KOHM. NO DATES WERE PROVIDED TO US. HOWEVER, THE DEVICE HAS BEEN RETURNED FOR ANALYSIS SO IT WAS EXPLANTED. THIS IS ALL THE INFORMATION AVAILABLE TO USE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291663 PHILOS II DR PACEMAKER DXY BIOTRONIK SE & CO. KG 341826

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization