BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 12789373 · Received November 10, 2021

    Report

    Report Number
    2017865-2021-35677
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ABBOTT
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. NO X-RAY VIEWS HAVE BEEN PROVIDED TO ABBOTT, SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON THE 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 ABBOTT FOR ANALYSIS.

    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

    IT WAS REPORTED THAT, DURING AN IN-CLINIC FOLLOW UP, X-RAY IMAGING WAS PERFORMED AND EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689636 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ABBOTT 7002/65 2908531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention