BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4153672 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16527
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    February 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, ARTIFACTS, NO SENSING, AND NO CAPTURE WERE OBSERVED. THE LEAD ALSO EXHIBITED EXTERNALIZED CONDUCTORS. THE LEAD WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631850 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention