BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902604 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00338
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 1, 2012
    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
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL ABRASIONS WERE FOUND AT 7.4-8.5CM FROM DISTAL TIP. EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION DAMAGE WERE FOUND AT 12.7-16.0CM FROM DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. ETFE COATING ON CONDUCTORS WAS DAMAGED AT EXPLANT, BUT OTHERWISE INTACT AT THIS LOCA- TION. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION DAMAGES WERE FOUND AT 16.0-19.5CM FROM DISTAL TIP. ETFE WAS INTACT AT THIS LOCATION. INTERNAL INSULATION DAMAGES WERE FOUND AT 9.4-10.6CM AND 39.0-40.1CM FROM DISTAL TIP. ETFE WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION DAMAGE WAS FOUND UNDERNEATH SVC SHOCK COIL AT 25.4-25.6CM FROM TIP ELECTRODE. THE ETFE WAS INTACT. CAUSE OF NOISE UNDETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NORMAL FOLLOW UP, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. THE PATIENT REPORTED EXPERIENCING INAPPROPRIATE THERAPY. UPON INTERROGATION, NOISE WAS NOTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8795 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR