BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 75-BP

    MDR report key: 3241121 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-01991
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    March 16, 2012
    Report Date
    July 11, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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

    OUS MDR - IN (B)(6) 2011, THE LEFT VENTRICULAR LEAD HAD BEEN DISABLED DUE TO A SUSPICION OF A PARTIAL FRACTURE. THIS LEAD TO A WORSENING OF HEART FAILURE. ON (B)(6) 2012 THE LEAD WAS REVISED. THIS IS ALL OF THE AVAILABLE INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340983 COROX OTW-L 75-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368345

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization