BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4173946 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16694
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 7.7-8.7CM, 8.6-9.0CM, 16.7-17.4CM, AND 23.5-23.9CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR PATIENT ANATOMY. INTERNAL INSULATION ABRASION WAS NOTED AT 7.2-8.2CM AND 7.4-8.2CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND THE LEAD TIP WAS FOUND TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP, EXTERNALIZED CONDUCTORS WERE OBSERVED. DURING EXTRACTION PROCEDURE, CARDIAC TAMPONADE WAS OBSERVED. THE PATIENT UNDERWENT A PERICARDIOCENTESIS. THE PATIENT WAS STABLE AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655883 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7002/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention