BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2890001 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10731
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 17, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 15.4-15.5CM FROM THE DISTAL TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NO TED AT 10.7-12.8CM AND 26.9-27.1CM FROM THE DISTAL TIP ELECTRODE. THE ETFE COATING WAS INTACT AT THESE ABRASION LOCATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OR FOR DEVICE CHANGE-OUT DUE TO NORMAL ERI. EXTERNALIZED CONDUCTORS WERE NOTED VIA DIAGNOSTIC IMAGING. LEAD TO BE MONITORED.

    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 1590/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention (B)(4)