BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901230 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12639
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 16.0CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 11.7-13.7CM AND 12.5-12.6CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 2.2CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOW PACING LEAD IMPEDANCE. EXTERNALIZED CONDUCTORS WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381146 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention