BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984196 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00321
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    November 8, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASIONS WERE FOUND AT 10.5-15.4CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASIONS WERE FOUND AT 7.5-9.0CM AND 38.9-39.1CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASIONS WERE FOUND UNDER THE SVC SHOCK COIL AT 24.2-24.5CM AND 25.1- 25.3CM FROM DISTAL TIP. THE ETFE COAT TING WAS INTACT AT THESE LOCATIONS. AN INTERNAL INSULATION ABRASION WAS NOTED UNDER THE SVC SHOCK COIL AT 20.5-22.0CM FROM THE TIP; THE ETFE COATING OF ONE RV CONDUCTOR WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE FIELD OBSERVATION OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING INAPPROPRIATE THERAPY DUE TO NOISE. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. PATIENT WAS SYMPTOMATIC WITH COMPLAINTS OF RECURRENT SHOCKS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87114 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR