BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3781945 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10042
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 27, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD MEASURING 48.0CM WAS RETURNED IN THREE SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION, MEASURING 1.6CM WAS NOTED NEXT TO THE CUT END OF ONE OF THE LEAD SEGMENTS. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED. THE LEAD WAS EXPLANTED. PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258875 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention