BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3791212 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10541
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 21, 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 Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. INTERNAL INSULATION ABRASION WAS NOTED AT 10.1-11.5CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 8.2-10.8CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS NOTED AT 11.6-12.0CM FROM THE DISTAL TIP. THE RV CONDUCTOR ETFE COATING WAS ABRADED AND THE INNER COIL WAS EXPOSED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR FOLLOW UP, EXTERNALIZED CONDUCTORS VIA FLUOROSCOPY AND NOISE WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268971 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention V-243, 263180