BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 4220994 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17438
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 10, 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
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC AFTER RECEIVING A PATIENT NOTIFICATION FOR NON-SUSTAINED VENTRICULAR OVERSENSING DUE TO MYOPOTENTIAL OVERSENSING. THE DEVICE WAS REPROGRAMMED. PATIENT RETURNED BACK TO THE CLINIC THE NEXT DAY DUE TO ANOTHER NOTIFICATION FOR NON-SUSTAINED RV OVERSENSING. REVIEW OF SESSION RECORD NOTED CROSS-TALK. FURTHER REPROGRAMMING WAS PLANNED AND REMOTELY MONITOR DEVICE. NOISE CONTINUED TO BE SEEN WITH REMOTE MONITORING. DEVICE AND LEAD WILL BE REPLACED. PATIENT CONDITION WAS FINE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703031 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention CD2259-40, 1086166