BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901312 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12675
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 3, 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 DISTAL TIP MEASURING 53.7CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 6.8-8.5CM, 9.0-10.2CM, AND 10.8-11.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 12.4-14.5CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION WAS NOTED AT 10.0-11.4CM FROM THE DISTAL TIP. AT THE TIME OF EXPLANT THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WAS OBSERVED VIA X-RAY. LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION IS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380452 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1056T/86, GT113192