BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 4240554 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004054
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OJX
    PMA / PMN Number
    P070008
    Adverse Event
    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 DIAPHRAGMATIC STIMULATION. IT WAS REPLACED WITH A COMPETITORS LEAD. 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
    723208 COROX OTW-S 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization