BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1954980 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00128
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 28, 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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND INSULATION ABRASION FROM 12.9CM TO 13.4CM AND FROM 16.7CM TO 17.1CM FROM THE CONNECTOR PIN. THE ETFE COATING OF THE CONDUCTOR CABLES WAS DAMAGED IN THE ABRADED AREA AT 16.7CM TO 17.1CM. THE DAMAGE FOUND IS CONSISTENT WITH FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ICD WENT INTO RESET MODE DURING THERAPY DELIVERY, INDICATING A LEAD ANOMALY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE ICD AND LEAD WERE EXPLANTED AND REPLACED.

    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 1591/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention