BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW 75-UP STEROID

    MDR report key: 3232176 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01936
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 29, 2013
    Report Date
    July 2, 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 PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD REVEALED A DAMAGED IS-1 CONNECTOR AND A DEFORMATION OF THE CONDUCTOR COIL, WHICH RESULTED MOST LIKELY FROM THE EXPLANT PROCEDURE. DURING THIS ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN PARTICULAR, THE INSULATION OF THE LEAD WAS INTACT. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO NOISE ON (B)(6) 2013. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331637 COROX OTW 75-UP STEROID LV LEAD NKE BIOTRONIK SE & CO. KG 346542

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization