BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 6166017 · Received December 12, 2016

    Report

    Report Number
    2938836-2016-14590
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 18, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, FLUOROSCOPY WAS PERFORMED WHICH REVEALED THE LEAD WAS EXTERNALIZED NEAR THE RV COIL. THE PATIENT WILL BE MONITORED WITH FOLLOW-UPS. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817736 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. 7002/65 2918333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other