BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1073497 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02396
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 18, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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 THE REPORTED FIELD EVENT WAS NOT CONFIRMED. NORMAL LEAD COILS/CABLES CONTINUITIES AND LEAD INSULATION RESISTANCE WERE MEASURED ON THE RETURNED PORTION OF THE LEAD. ANALYSIS NOTED DAMAGE AT 8 - 10 CM FROM THE LEAD TIP, INDICATIVE OF LEAD ABRASION. THE APPEARANCE OF THE ABRADED SILICONE INSULATION AROUND THE EXPOSED SENSING CABLES INDICATED THAT THAT THE LEAD MOST LIKEY WAS IN A BENT POSITION, LEADING TO AN ABRASION. THE DAMAGES OBSERVED COULD HAVE CAUSED HIGH CAPTURE THRESHOLD.

    Description of Event or Problem · 1

    AFTER SEVERAL FOLLOW-UPS WITH HIGH THRESHOLDS, PHYSICIAN DECIDED TO EXPLANT THE LEAD. LEAD DAMAGE WAS SUSPECTED. THERE WERE NO CONSEQUENCES, AND THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER EVENT.

    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