BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3943997 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13437
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC AFTER RECEIVING AN ALERT FOR LOW HIGH VOLTAGE LEAD IMPEDANCE. A SINGLE OUT OF RANGE MEASUREMENT WAS NOTED ON REVIEW OF THE DIAGNOSTICS. THE OUT OF RANGE MEASUREMENT COULD NOT BE REPRODUCED IN-CLINIC. REMOTE MONITORING WILL CONTINUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT CAME INTO THE CLINIC AFTER RECEIVING AN ALERT. A STORED EPISODE SHOWED OVERSENSING DUE TO LEAD NOISE. THE NOISE WAS REPRODUCED WITH POCKET MANIPULATION. THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD WAS DISCARDED IN THE FIELD. THE PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422390 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention