BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIA DR-T

    MDR report key: 3040794 · Received April 8, 2013

    Report

    Report Number
    1028232-2013-00939
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS BOL. THE INSPECTION OF THE PACEMAKER MEMORY REVEALED NO ANOMALIES. THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. 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 SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION. MEDTRONIC, BOSTON SCIENTIFIC, ST JUDE MEDICAL AND SORIN MEDICAL HAVE NO RECORD OF THIS PATIENT. THE FOLLOWING PHYSICIAN'S OFFICE WOULD NOT RETURN PHONE CALLS REGARDING THIS PATIENT. THE HOSPITAL HAS NO RECORD OF THIS PATIENT. RECORDS INDICATE THAT THIS PATIENT WAS LIVING AT BEHAVIOR CENTER; HOWEVER THEIR RECORDS INDICATE THAT THE PATIENT HAS NOT BEEN IN THEIR FACILITY FOR TWO YEARS. THE DATE AND REASON FOR EXPLANT ARE UNKNOWN. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144166 EVIA DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization