BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955029 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00096
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 19, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO DELAY IN RECEIVING PAPERWORK. THE LEAD WAS RETURNED IN TWO PIECES. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. A COMPLETED EVALUATION COULD NOT BE PERFORMED SINCE THE LEAD WAS RETURNED IN TWO PIECES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO HIGH THRESHOLD AND HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention