BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3854717 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11505
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ELECTIVE DEVICE REPLACEMENT, EXTERNALIZED CONDUCTORS WERE OBSERVED UNDER FLUOROSCOPY. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. THE LEAD WAS CAPPED AND REPLACED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330987 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR