BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 12210717 · Received July 22, 2021

    Report

    Report Number
    2017865-2021-25861
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    July 8, 2021
    Report Date
    September 16, 2021
    Manufacturer
    ABBOTT
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO X-RAY VIEWS HAVE BEEN PROVIDED TO ST. JUDE MEDICAL SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON EVENT DESCRIPTION WE REGARD THIS AS A CASE OF EXTERNALIZED CABLES. NO FURTHER ANALYSIS CAN BE PERFORMED SINCE THE LEAD WILL NOT BE RETURNED TO ST. JUDE MEDICAL FOR ANALYSIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

    Additional Manufacturer Narrative · 1

    NO X-RAY VIEWS HAVE BEEN PROVIDED TO ST. JUDE MEDICAL SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON EVENT DESCRIPTION WE REGARD THIS AS A CASE OF EXTERNALIZED CABLES. NO FURTHER ANALYSIS CAN BE PERFORMED SINCE THE LEAD WILL NOT BE RETURNED TO ST. JUDE MEDICAL FOR ANALYSIS.

    Description of Event or Problem · 1

    DURING A REMOTE FOLLOW-UP, OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. AN X-RAY WAS PERFORMED AND EXTERNALIZATION OF THE LEAD CONDUCTORS WAS CONFIRMED. A LEAD REPLACEMENT IS ANTICIPATED, BUT NOT YET PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105836 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ABBOTT 1581/65 3022783

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention