BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2962794 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00088
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE TIP MEASURING 52.7CM WAS RETURNED FOR ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 7.4-10.0CM AND 10.4-12.7CM FROM THE DISTAL TIP. THE ETFE COATING WAS DAMAGED DUE TO THE SURGICAL PROCEDURE AT THESE LOCATIONS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 10.0-12.0CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASIONS WERE NOTED AT 23.1-23.6CM AND 23.3-24.0CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT DURING EXTRACTION PROCEDURE, A TEAR DEVELOPED AT THE SVC-RA JUNCTION AND THE PHYSICIAN OPENED THE CHEST TO INTERVENE. THE TEAR WAS REPAIRED SUCCESSFULLY. PATIENT CONDITION IS STABLE AFTER THE EVENT.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT THE PREVIOUSLY CAPPED LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO NOISE. EXTERNALIZED CONDUCTORS WERE NOTED VIA FLUOROSCOPY. LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64715 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR