BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 3952891 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002667
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    February 22, 2013
    Report Date
    June 19, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER WAS IMPLANTED FOR 24 MONTHS. IT WAS EXPLANTED ON (B)(6) 2013 AND RECEIVED FOR ANALYSIS ON JULY 2014. UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED REVEALING A BURN MARK ON THE PACEMAKER HOUSING. AT A NEXT STEP THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE EVALUATION OF THE MEMORY CONTENT REVEALED THAT THE DEVICE SWITCHED TO THE "ERI" STATUS ON (B)(6) 2012. DURING THE INSPECTION, THE PACEMAKER COULD NOT BE INTERROGATED AND NO ANTI-BRADYCARDIA THERAPY WAS PRESENT. THEREFORE THE PACEMAKER WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES AND THE BATTERY WAS FOUND TO BE FULLY DEPLETED BUT NOT DEFECTIVE. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. AFTER AN IMPLANTATION DURATION OF 24 MONTHS AND TAKING INTO ACCOUNT THE HIGH PROGRAMMED OUTPUT IN THE RV CHANNEL (6V@1MS), THE BATTERY CONDITION "ERI" ON (B)(6) 2012 WAS ANTICIPATED. FURTHERMORE, THE CURRENT BATTERY DEPLETION IS EXPECTED AFTER MORE THAN 3 YEARS SINCE THE "ERI" STATUS DECLARATION. AT A NEXT STEP THE ELECTRONIC MODULE WAS ATTACHED TO AN EXTERNAL POWER SUPPLY. AN INTERROGATION OF THE DEVICE WAS PROPERLY FEASIBLE AND THE ANTI-BRADYCARDIA THERAPY FUNCTIONS PROVED TO BE WITHIN SPECIFICATION. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. IN SUMMARY, THE BATTERY OF THE PACEMAKER WAS FOUND TO BE FULLY DEPLETED BUT NOT DEFECTIVE. THE BATTERY CONDITION WAS ANTICIPATED. THE ELECTRONIC MODULE WAS ATTACHED TO AN EXTERNAL POWER SUPPLY AND THE DEVICE PROVED TO BE WITHIN SPECIFICATION. IN PARTICULAR THE CURRENT CONSUMPTION WAS NORMAL. THE ANALYSIS OF THE PACEMAKER REVEALED NO INDICATIONS OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE IS AT ERI INDICATION DUE TO HIGH THRESHOLDS ON THE COMPETITIVE EPICARDIAL RA LEAD. THE PHYSICIAN ALSO REPLACED THE ATRIAL LEAD AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430259 EVIA DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization