BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COROX OTW-S 75-BP

    MDR report key: 1913511 · Received November 24, 2010

    Report

    Report Number
    1028232-2010-02625
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 15, 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

    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. WE WOULD LIKE TO CHANGE THIS OUTCOME TO OTHER SERIOUS.

    Additional Manufacturer Narrative · 1

    (B)(4) 2014 - THIS LEAD WAS CAPPED AND REPLACED DURING A NORMAL DEVICE CHANGE OUT ON (B)(6) 2014.

    Description of Event or Problem · 1

    HIGH THRESHOLDS WERE NOTED ON THIS LEAD, ALONG WITH INTERMITTENT CAPTURE. THE PHYSICIAN ELECTED TO PROGRAM THIS LEAD OFF AND DISABLE CRT THERAPY. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention