BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2962816 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00106
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    September 20, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 13.9CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 12.3-13.2CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THIS LOCATION. EXTERNAL INSULATION ABRASION WERE FOUND AT 11.2-11.4CM AND 12.9-13.2CM FROM THE CONNECTOR PIN, CONSISTENT WITH FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO EXTERNALIZED CONDUCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64479 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR