BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210487 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03249
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD MEASURING 64.3CM FROM THE DISTAL TIP WAS RETURNED FOR ANLAYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE OBSERVED AT 12.5-14.6CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT. INTERNAL INSULATION ABRASIONS UNDER THE SVC SHOCK COIL WERE NOTED AT 21.0-22.8CM, 21.6-22.3CM, AND 22.5-24.2CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH HV LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311082 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention