BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1955151 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00180
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 5, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A VIBRATORY ALERT FOR IMPEDANCE OUT OF RANGE. IT WAS NOTED THAT THE IMPEDANCE HAS CONTINUALLY BEEN OUT OF RANGE. THE SENSING AND PACING WERE WITHIN NORMAL LIMITS. THE PATIENT NOTIFIER WAS TURNED OFF AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR