BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 3791123 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10466
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    November 11, 2011
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH CAPTURE THRESHOLD ON THE LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. THE DEFIBRILLATION PORTION OF THE LEAD REMAINED ACTIVE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268854 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention