BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3872981 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11851
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 16, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION: A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 23.5CM WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO CLAVICULAR CRUSH THAT RESULTED IN FRACTURE. THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS FINE AFTER THE EVENT.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE PROXIMAL TRIFURCATION OF THE LEAD WAS EXPLANTED AND RETURNED. THE REST OF THE LEAD REMAINS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350051 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention (B)(4)