BEUDAMED
    FDA Adverse Event Death Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 2172047 · Received July 15, 2011

    Report

    Report Number
    1028232-2011-01557
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    May 13, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO A LEAD FRACTURE AND WAS REPLACED WITH A COMPETITOR'S EPICARDIAL LEAD. WE WERE INFORMED THAT THE PATIENT EXPIRED ON (B)(6) 2011. THIS LEAD WAS RETAINED BY PATHOLOGY. THIS IS ALL OF THE AVAILABLE INFORMATION AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H