BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955050 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00126
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 26, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MODEL AND SERIAL NUMBER FOR THIS LEAD WAS PREVIOUSLY REPORTED AS 1582/65, (B)(4). THIS REPORT NOTES THE CORRECT MODEL AND SERIAL NUMBER. A PARTIAL LEAD MEASURING 5.0CM WAS RETURNED FOR ANALYSIS. THE OUTER INSULATION WAS BREACHED FOR 0.5CM AND 1.0CM IN THE MIDDLE OF THE RETURNED PORTION OF THE LEAD. THE ETFE COATING WAS ABRADED AT THESE LOCATIONS. A FRACTURE OF THE CONDUCTOR AND INNER COIL WAS NOTED AT ONE END OF THE LEAD, CONSISTENT WITH FATIGUE AND EXTERNAL INSULATION ABRASION.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT EXTERNALIZED CONDUCTORS WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VISIT, AN INSULATION BREAK WAS NOTED. REVIEW OF FLUOROSCOPY SHOWED THE LEAD HAD WRAPPED ITSELF LIKE A SPIRAL WITHIN ITSELF. THE HIGH VOLTAGE LEAD IMPEDANCE HAD DECREASED AND THE PACING LEAD. IMPEDANCE HAD INCREASED. THE LEAD WAS CAPPED.

    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 Required Intervention