BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1955126 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00159
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 9, 2010
    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 Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED NOISE WAS CONFIRMED IN THE LABORATORY. AN INSULATION ABRASION WAS NOTED AT 30.3CM TO 30.9CM FROM THE DISTAL TIP. THE RV CABLES WERE BROKEN. THE INNER INSULATION WAS ALSO ABRADED AT THE SAME AREA. THE DAMAGE FOUND IS CONSISTENT WITH THAT OF FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON BOTH ATRIAL AND VENTRICULAR LEADS. THE NOISE HAD RESULTED IN AN INAPPROPRIATE SHOCK. DURING EXPLANT, THE PHYSICIAN OBSERVED THAT THE ATRIAL LEAD WAS WEARING AWAY THE INSULATION OF THE VENTRICULAR LEAD. THE LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)