BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3884796 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12193
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED: COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD MEASURING 42.5CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 25.4-25.7CM FROM THE CUT END OF THE RV SHOCK COIL, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. THE SILICONE INSULATION WAS INTACT AT THIS LOCATION. (B)(6).

    Additional Manufacturer Narrative · 1

    NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD MEASURING 42.5CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 6.5-7.1CM FROM THE PROXIMAL END OF THE SVC SHOCK COIL, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. THE SILICONE INSULATION WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360155 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1