BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2950123 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00027
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 5, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY LABORATORY TECHNICIAN; (B)(6). NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO BOTH EXTERNAL AND INTERNAL ABRASION AT 10.3-12.8CM AND EXTERNAL ABRASION AT 29.0-31.7CM FROM THE TIP. THE SILICONE WAS ABRADED AND THE CONDUCTORS WERE VISIBLE. INTERNAL ABRASION AT 17.9-18.2CM AND BOTH EXTERNAL AND INTERNAL ABRASION AT 20.9-21.2CM FROM THE TIP. THE (B)(4) COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53654 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1