BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOROX OTW 85-BP

    MDR report key: 1913510 · Received November 24, 2010

    Report

    Report Number
    1028232-2010-02642
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 16, 2010
    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 IMPLANTED AND EXPLANTED ON (B)(6) 2010 BECAUSE, IT HAD UNACCEPTABLE NUMBERS AND WAS REPLACED WITH A DIFFERENT FIXATION LEAD. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THIS FILE WILL BE UPDATED IF MORE INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOROX OTW 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 354807

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization