BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955266 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00108
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 23, 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 Location
    NJ
    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

    PATIENT PRESENTED TO THE CLINIC WITH SEVERAL VF EPISODES OF NOISE WERE DETECTED AND MARKED AS VF. THE NOISE WAS SHORT IN DURATION THAT THE PATIENT DID NOT RECEIVE THERAPY. EGM SHOWED NOISE ON BOTH THE RV COIL TO CAN AND V SENSE/PACE. ARM MOVEMENTS WERE PERFORMED WITHOUT RECREATING THE NOISE. THE PATIENT WAS BROUGHT IN FOR ICD CHANGE DUE TO NEARING ERI AND TO REPLACE THE LEAD. HOWEVER, PATIENT WAS ANXIOUS AND SO, THE SURGERY WAS POSTPONED. PATIENT IS BEING MONITORED

    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 1582/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR