BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901358 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12679
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A NORMAL FOLLOW UP. DIAGNOSTIC IMAGING REVEALED EXTERNALIZED CONDUCTORS. PATIENT WAS ASYMPTOMATIC. VARIATION IN LOW PACING LEAD IMPEDANCE WAS NOTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380514 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1591/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention