BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4153597 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16516
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 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. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 19.6-20.2CM AND 20.3-20.5CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 18.6-19.3CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS ABRADED 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
    631737 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7010/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1