BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223423 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03652
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    September 12, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. THE PROXIMAL PORTION OF THE LEAD WAS RETURNED. AN ABRASION AT 22.4 CM FROM THE PIN WAS ABRADED THROUGH. THE RV CABLE CONDUCTORS UNDER THE ABRASION WERE EXPOSED, BUT INTACT. THE ABRASION IS CONSISTENT WITH FRICTION TO THE ICD CAN. THE PARTIAL LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.

    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
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1