BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3884839 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12205
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 7, 2014
    Report Date
    August 2, 2017
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE MIDDLE PORTION MEASURING 33.7CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW UP. FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS ON THE RV LEAD. NO ELECTRICAL ANOMALIES NOTED. LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THE LEAD WAS EXPLANTED DUE TO UNRELATED TO THE DEVICE ISSUE. THE PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359851 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR