BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 4071741 · Received August 27, 2014

    Report

    Report Number
    1028232-2014-03028
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    March 19, 2014
    Report Date
    August 7, 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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT HAD TORTUOUS ANATOMY AND THIS LEAD "TOOK ON THE SHAPE OF THE ANATOMY". THE PHYSICIAN DECIDED TO REPLACE THIS LEAD WITH A NEW LV LEAD. THIS DEVICE WAS RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519683 COROX OTW-S 85-BP LV LEAD OJX BIOTRONIK SE & CO. KG 355149

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization