BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2984175 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00380
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 15, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD CUT IN TWO SEGMENTS WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 42.1-42.7 CM FROM THE DISTAL TIP, CONSISTENT WITH FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION. ELECTRICAL MEASUREMENTS THAT COULD BE PERFORMED RESULTED IN NORMAL VALUES.

    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
    86489 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1