BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4220991 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17384
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    July 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 32.4CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 25.3-26.1CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING AS ABRADED AT THIS LOCATION, CONSISTENT WITH THE FIELD OBSERVATION OF NOISE, INAPPROPRIATE THERAPY, AND LOW PACING LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE HIGH VOLTAGE THERAPIES DUE TO NOISE ON THE RIGHT VENTRICULAR LEAD. A DECREASE IN PACING LEAD IMPEDANCE AND LEAD FRACTURE WERE ALSO NOTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703030 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention