BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3854733 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11595
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 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 Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW PACING LEAD IMPEDANCE WAS OBSERVED. THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS FINE AND THE SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331166 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention