BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW 85-UP STEROID

    MDR report key: 3241165 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-01990
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P050023
    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 ASSOCIATED WITH THE MANUFACTURE OF 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

    THIS LEAD WAS CAPPED AND REPLACED DUE TO A FRACTURE. THE RV LEAD WAS ALSO FRACTURED AND WHEN THE PHYSICIAN WENT IN TO EXTRACT THE LEADS, THE SVC RUPTURED AND THE PHYSICIAN DECIDED TO LEAVE THE LEADS IN AND CAP THEM AND THEN IMPLANT A NEW SYSTEM ON THE RIGHT SIDE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340884 COROX OTW 85-UP STEROID LV LEAD NKE BIOTRONIK SE & CO. KG 346543

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization