BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2890012 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10701
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 10, 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. RELIABILITY LABORATORY TECHNICIAN; (B)(6). NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 7.5CM-9.0CM FROM DISTAL TIP CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. INTERNAL INSULATION ABRASION WAS FOUND AT 35.2CM-36.2CM FROM DISTAL TIP. ETFE COATING WAS BREACHED AT BOTH LOCATIONS. INSULATION DAMAGE WAS FOUND AT 48.2CM FROM DISTAL TIP CONSISTENT WITH CLAVICLE CRUSH DAMAGE.

    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 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1