BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4130889 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16149
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 7, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 57.2CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 38.9-39.2CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 10.0-12.5CM AND 10.2-12.6CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION WAS NOTED AT 29.7-29.9CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP, EXTERNALIZED CONDUCTORS WERE NOTED ON THE RIGHT VENTRICULAR LEAD. THE ELECTRICAL FUNCTION OF THE LEAD WAS TESTED AND A SLIGHT ELEVATION IN CAPTURE THRESHOLD WAS NOTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607449 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention