BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 6200849 · Received December 22, 2016

    Report

    Report Number
    2938836-2016-21353
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Report Date
    December 9, 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.

    Description of Event or Problem · 1

    FLUOROSCOPY SHOWED THAT THE LEAD WAS EXTERNALIZED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849733 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. 1570/65 3040451

    Patients

    Seq Age Sex Outcome Treatment
    1