BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 4153598 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16416
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 5, 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 Occupation
    PHYSICIAN

    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 AN INCREASE IN CAPTURE THRESHOLD AND LOSS OF CAPTURE WERE OBSERVED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631899 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7022/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention