BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1954824 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00177
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 14, 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
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD WAS RETURNED MEASURING 22.4CM. A VISUAL INSPECTION REVEALED INSULATION ABRASIONS FROM 13.7CM TO 14.3CM AND 15.2CM TO 15.8CM FROM THE CONNECTOR TIP. THE ETFE COATINGS OF THE IS-1 CABLES WERE ABRADED AT 13.9CM FROM THE CONNECTOR TIP. THE DAMAGE FOUND IS CHARACTERISTIC OF FRICTION WITH THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ABORTED VF EPISODE WAS NOTED DURING A FOLLOW-UP VISIT. NOISE WAS OBSERVED ON THE VENTRICULAR AND ATRIAL LEADS. THE PHYSICIAN SUSPECTED A HEADER ISSUE. THE LEAD AND DEVICE 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 7001/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention (B)(4)