BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW 85-BP

    MDR report key: 1893603 · Received November 1, 2010

    Report

    Report Number
    1028232-2010-02326
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    August 5, 2010
    Report Date
    October 5, 2010
    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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    PER PT TRACKING, THIS LEAD WAS EXPLANTED BECAUSE IT HAD DISLODGED INTO THE CS. A MYOPORE (B)(4) WAS IMPLANTED IN ITS PLACE. THERE WERE NO ADVERSE PT EVENTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization