BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2950142 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00020
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 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 INTERNAL INSULATION ABRASIONS WERE FOUND AT 7.5 CM TO 8.3CM, 10.0 CM TO 11.5 CM AND 17.2 CM TO 18.9 CM FROM THE DISTAL TIP. EXTERNAL INSULATION ABRASION WAS FOUND AT 43.9 CM TO 44.1 CM FROM THE DISTAL TIP CONSISTENT WITH LEAD FRICTION TO THE ICD. THE (B)(4) COATING OF THE CONDUCTORS WAS INTACT AT THE ABRASION SITES.

    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
    54498 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1