BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 75-BP

    MDR report key: 2933098 · Received January 23, 2013

    Report

    Report Number
    1028232-2013-00118
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    October 14, 2011
    Report Date
    January 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT WAS ADMITTED TO THE HOSPITAL (B)(6) 2011 FOR WORSENING HEART FAILURE. DURING ADMISSION BLOOD CULTURES WERE DONE AND CAME BACK POSITIVE. ECHO REVEALED POSSIBLE LESIONS ON PACER LEADS. DEVICE LEADS WERE REMOVED ON (B)(6) 2011. DEVICE WAS NOT REMOVED. SUBJECT RECEIVED SEVERAL ROUNDS OF IV ANTIBIOTICS THROUGHOUT HOSPITAL COURSE. SUBJECT WAS D/C'D ON (B)(6) 2011 WITH NO CLINICAL SIGNS OF INFECTION. NO PLANS TO IMPLANT NEW LEADS OR REMOVE DEVICE MENTIONED AT TIME OF D/C. THIS IS ALL THE AVAILABLE INFORMATION AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33255 COROX OTW-S 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG. 355148

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization