BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955102 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00073
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 4, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP, AND IT WAS OBSERVED THAT THE PATIENT HAD OCCASIONAL PALPITATIONS, LIKELY DUE TO ATRIAL FIBRILLATION. THE PATIENT HAS AF WITH LOW PACING FROM THE DEVICE. DECREASE IN SENSING WAS ALSO NOTED. ON (B)(6) 2010, THE PHYSICIAN OPTED TO CAP AND REPLACE THE SENSE/PACE PORTION OF THE LEAD. THE DEFIB PORTION REMAINS ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention