BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 4153713 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16328
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 23, 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
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS. NO ELECTRICAL ANOMALIES WERE NOTED. LEAD WAS CAPPED AND REPLACED DURING DEVICE CHANGE OUT FOR NORMAL ERI. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632023 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1