BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 9678331 · Received February 6, 2020

    Report

    Report Number
    2938836-2020-00951
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 22, 2020
    Report Date
    March 24, 2020
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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 FOLLOW-UP, EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. EXPLANT OF THE RV LEAD WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141150 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ABBOTT 7002/65 2918292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R