BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4031752 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14774
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    June 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PARTIAL LEAD MEASURING 58.1CM WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 39.7-40.4CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. INTERNAL INSULATION ABRASION WAS NOTED AT 8.2-8.8CM AND 13.6-15.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED FOR DEVICE CHANGE OUT DUE TO NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE DETECTED. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THE PATIENT PRESENTED TO THE CLINIC FOR LEAD NOISE. THE LEAD WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510138 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR