BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS II DR

    MDR report key: 3891465 · Received June 24, 2014

    Report

    Report Number
    1028232-2014-002123
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 13, 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

    THE PACEMAKER WAS RECEIVED FOR ANALYSIS. PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS FOR THIS PACEMAKER WERE RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE AS SPECIFIED. AS A FIRST STEP OF THE PACEMAKER ANALYSIS A VISUAL INSPECTION WAS PERFORMED, REVEALING SCRATCHES ON THE PACEMAKER HOUSING. THESE WERE CONSIDERED TO BE NORMAL AND EXPECTED MOST LIKELY DUE TO THE EXPLANTATION PROCEDURE. THE DEVICE INTERROGATION CONFIRMED THE CLINICAL OBSERVATION, THE PACEMAKER SWITCHED TO THE BATTERY STATUS ERI ON (B)(6) 2014. THE PACEMAKER'S MEMORY CONTENT WAS INVESTIGATED REVEALING NO ANOMALIES, IN PARTICULAR THE CURRENT CONSUMPTION WAS FOUND TO BE NORMAL AND EXPECTED. 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. THE PACEMAKER WAS IMPLANTED FOR 89 MONTHS. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. IN SUMMARY, THE PACEMAKER WAS FULLY FUNCTIONAL. THE BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 89 MONTHS, A BATTERY DEPLETION WAS REPORTED IN (B)(6) 2014. DURING THE LAST FOLLOW-UP ON (B)(6) 2014, THE DEVICE INDICATED 9 MONTHS REMAINING LONGEVITY. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369337 PHILOS II DR PACEMAKER DXY BIOTRONIK SE & CO. KG 341826

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization