BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3801362 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10980
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 7, 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
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC, INTERMITTENT UNDERSENSING WAS OBSERVED ON A STORED VT EPISODE. INSULATION ANOMALY WAS ALSO NOTED. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278893 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention