BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1895598 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04413
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 9, 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 RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE ON THE VENTRICULAR LEAD. THE PATIENT WILL BE TRANSFERRED TO A HOSPITAL FOR POSSIBLE REVISION.

    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 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1