BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 6335607 · Received February 16, 2017

    Report

    Report Number
    2938836-2017-14939
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    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 DEVICE REPLACEMENT, A LEAD EXTERNALIZATION WAS NOTED ON FLUOROSCOPY. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT IS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117482 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. 1570/65 2915535

    Patients

    Seq Age Sex Outcome Treatment
    1