BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 85-BP

    MDR report key: 1873099 · Received October 15, 2010

    Report

    Report Number
    1028232-2010-02200
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    May 21, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    LEAD DISLODGEMENT WAS SUSPECTED AND WAS CONFIRMED BY X-RAY. THE LEAD WAS SUCCESSFULLY REPOSITIONED. ALL RECORDS INDICATE THAT THE LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT 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 73 YR Hospitalization