BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2950167 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00014
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 28, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN THE OR FOR CHANGE OUT DUE TO NORMAL ERI. EXTERNALIZED CONDUCTORS WERE NOTED. NO ELECTRICAL ANOMALIES WERE DETECTED. PLANS ARE TO REPLACE THE LEAD.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATED THAT THE LEAD WAS CAPPED AND REPLACED WHEN PATIENT PRESENTED FOR AN ELECTIVE DEVICE CHANGE-OUT. PATIENT CONDITION WAS NORMAL POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54888 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR