BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3220185 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04256
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 9, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED EXTERNAL INSULATION ABRASION WAS FOUND AT 10.5-11.1, 20.6-20.7, 20.7-20.9CM, AND 30.50.7CM FROM THE ELECTRODE TIP, CONSISTENT WITH FRICTION TO ANOTHER DEVICE. INTERNAL INSULATION ABRASION WAS FOUND AT 11.3-13.0CM FROM THE DISTAL TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE EFTE COATING WAS INTACT AT ALL ABRASION LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE OR FOR LV LEAD REVISION DUE TO DISLODGEMENT. VIA DIAGNOSTIC IMAGING EXTERNALIZED CONDUCTORS WERE OBSERVED. ELECTRICAL MEASUREMENTS WERE NORMAL. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320876 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention 1056T/86, GT101064