BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 3031208 · Received April 2, 2013

    Report

    Report Number
    1028232-2013-00937
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 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
    OR, US
    Reporter Occupation
    NURSE

    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 PACEMAKER WAS SUBJECTED TO AN ELECTRICAL INCOMING INSPECTION. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED IN ERI-MODE. THE PACEMAKER WAS SUCCESSFULLY INTERROGATED AND THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED INDICATING THAT THE DEVICE SWITCHED TO THE BATTERY STATUS "ERI" ON (B)(6) 2013. FURTHERMORE, THE BATTERY HISTORY WAS EVALUATED INDICATING NO ELEVATED CURRENT CONSUMPTION. THE BATTERY VOLTAGE WAS AS EXPECTED FOR A FULLY CHARGED BATTERY. A RESET OF THE "ERI" STATUS WAS SUCCESSFULLY PERFORMED. SUBSEQUENT INTERROGATION YIELDED THE BATTERY STATUS "OK". A STRESS TEST UNDER DIFFERENT TEMPERATURE ENVIRONMENTS WAS PERFORMED. THE BATTERY STATUS OF THE DEVICE WAS AS EXPECTED. DURING A DETAILED INVESTIGATION OF THE RETURNED DEVICE DATA IT WAS NOTICED, THAT THE BATTERY STATUS WAS NOT TRIGGERED BY A PERMANENTLY DEPLETED BATTERY. MOREOVER, A COMBINATION OF A TEMPORARY SLIGHT AND REVERSIBLE DROP IN BATTERY VOLTAGE AS WELL AS AN EXTREME HIGH CURRENT CONSUMPTION PROGRAM (7.0V AT 1.0MS) TRIGGERED THE BATTERY STATUS "ERI". IN SUMMARY, THE ANALYSIS REVEALED THAT THE BATTERY STATUS "ERI" WAS NOT DECLARED BY A PREMATURE BATTERY DEPLETION. INSTEAD, A TEMPORARY DROP IN SUPPLY VOLTAGE IN COMBINATION WITH AN EXTREME HIGH OUTPUT PROGRAM LED THE DEVICE TO SWITCH INTO THE BATTERY STATUS "ERI".

    Description of Event or Problem · 1

    THE ASSOCIATED LEAD DISPLAYING HIGH THRESHOLDS WITH AN ERROR MESSAGE REPORTING HIGH CURRENT DRAIN. THE DECISION WAS MADE TO REOPEN THE POCKET TO REVISE THE LEAD. HOWEVER, DUE TO FURTHER INQUIRY WE LEARNED THAT THE ASSOCIATED LEAD WAS LEFT IMPLANTED, BUT THIS DEVICE WAS EXPLANTED AND REPLACED BECAUSE THE ERROR MESSAGE HAD TRIGGERED ERI. (B)(6) 2013 - THIS DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134592 EVIA DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization