BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2962782 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00087
    Event Type
    Injury
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS FOUND AT 15.8-16.0CM FROM THE LEAD TIP. INTERNAL INSULATION ABRASION WAS FOUND AT 8.9- 10.8CM FROM THE LEAD TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 3.8-6.0CM FROM THE LEAD TIP. INTER- NAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 25.2-25.4CM FROM THE LEAD TIP. THE ETFE COATING WAS INTACT. INTERNAL ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 17.3-17.4CM FROM THE LEAD TIP. THE ETFE COATING WAS ABRADED AT THIS LOCATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THAT THE LEAD WAS EXPLANTED WITH NO CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, EXTERNALIZED CONDUCTORS WERE SEEN UNDER FLUOROSCOPY. DECREASED R-WAVE WAS NOTED. THE LEAD WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64944 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention