BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4221100 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17488
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 24, 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. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD MEASURING 39.2CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 3.9-4.3CM FROM THE PROXIMAL END OF THE SVC SHOCK COIL, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. THE SILICONE INSULATION WAS INTACT AT THIS LOCATION. (B)(4).

    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
    702903 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1