BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA HF-T

    MDR report key: 3984508 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002752
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    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

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS "OK". THE DEVICE WAS IMPLANTED FOR 19 MONTHS. THE INSPECTION OF THE PACEMAKER'S 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 AND 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

    WHILE THE PHYSICIAN REPLACED THE COMPETITORS LV LEAD DUE TO DIAPHRAGMATIC STIMULATION AND HIGH CAPTURE THRESHOLDS, THIS PACEMAKER WAS EXPLANTED AND REPLACED. THE HOSPITAL RETAINED THIS DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460269 EVIA HF-T PACEMAKER NKE BIOTRONIK SE & CO. KG 377208

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization