BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AROX 53-BP

    MDR report key: 3874213 · Received June 16, 2014

    Report

    Report Number
    1028232-2014-01981
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K021217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED AND REPLACED DUE TO DECREASING SENSING R WAVES TO .5MV AND RISING IMPEDANCES OF >1500 OHMS. AT THE TIME OF THIS LEAD BEING CAPPED, THE R WAVES WERE AT 1.7 AND IMPEDANCES WERE >3200 OHMS. THERE WAS NO OBVIOUS SIGN OF FRACTURE ON FLUOROSCOPY. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352306 AROX 53-BP PACER LEAD DTB BIOTRONIK SE & CO. KG 338023

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization