BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3781797 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09933
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 28, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS NOTED AT 7.4-9.0CM FROM THE LEAD TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING, SHORT V-V INTERVALS WERE OBSERVED VIA REMOTE TRANSMISSION. PATIENT PRESENTED FOR LEAD EXTRACTION AND EXTERNALIZED CONDUCTORS WERE NOTED PROXIMAL TO THE RV COIL. THE PATIENT WAS STABLE AFTER THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260328 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention