BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 75-BP

    MDR report key: 3843175 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01871
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P070008
    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 EXPLANTED AND REPLACED DUE TO LOSS OF CAPTURE. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321255 COROX OTW-L 75-BP LV LEAD OJX BIOTRONIK SE & CO. KG 368345

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization