BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 75-BP

    MDR report key: 2113599 · Received May 24, 2011

    Report

    Report Number
    1028232-2011-01164
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NKE
    PMA / PMN Number
    P070008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 11 MONTHS, THIS LEAD WAS REPORTED TO HAVE A HELIX FRACTURE OF THE VENTRICULAR LEAD. NO EXPLANTED DATE WAS PROVIDED AND NO MENTION OF ANY INTERVENTION. THEREFORE, ALL AVAILABLE INFO SUGGESTS THIS LEAD IS STILL IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other