BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COROX OTW-L 85-BP

    MDR report key: 3232136 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01929
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 8, 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

    IT WAS NOTED DURING THE ANALYSIS THAT THE INSULATION OF THE LEAD BODY WAS DAMAGED BY SQUASHING ABOUT 31 CM DISTAL OF THE CONNECTOR PIN. IN ADDITION, THE ROPE CONDUCTORS TO THE RING ELECTRODE AND TIP ELECTRODE SHOWED A CONDUCTOR FRACTURE AT THIS SITE. THIS DAMAGE MANIFESTATION CONFIRMS THE CLINICAL COMPLAINT. THE OBSERVED DAMAGE MANIFESTATION REQUIRES EXCESSIVE PRESSURE STRESS ONTO THE LEAD BODY. THE CHARACTERISTICS OF THE DAMAGED STRUCTURE OF THE LEAD BODY (SQUASHING) LEAD TO THE ASSUMPTION OF EXCESSIVE MECHANICAL STRESS OF THE LEAS DUE TO THE "SUBCLAVIAN CRUSH SYNDROME". THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - LEAD FRACTURE IS SUSPECTED. THE PHYSICIAN POINTED OUT AN AREA OF THE LEAD (ABOUT 25 CM DISTANT FROM THE CONNECTOR), AT WHICH THE LEAD SHOWED VISIBLE DAMAGE. THE LV LEAD COULD NO LONGER BE MEASURED. THE PATIENT WAS IMPLANTED WITH AN EPICARDIAL LEAD. THE IMPLANT DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330754 COROX OTW-L 85-BP LV LEAD NKE BIOTRONIK SE & CO. KG 368346

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization