BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2890195 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10635
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 12, 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 A PARTIAL LEAD WAS RETURNED, CUT INTO TWO SEGMENTS. INTERNAL INSULATION ABRASION WAS FOUND AT 27.3 CM TO 29.0 CM FROM THE DISTAL TIP. THE ETFE COATING OF THE CONDUCTORS WAS INTACT AT THE ABRASION SITE. (B)(6). NO COMPLAINT RECEIVED WITH THE RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS.

    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 NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1