BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2243007 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06147
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    June 28, 2011
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 28.4CM IN LENGTH WAS RETURNED. ANALYSIS OF THE RETURNED PORTION WAS NORMAL. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. WITHOUT RETURN OF THE ENTIRE LEAD A FULL ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT DEVICE CHANGE-OUT FOR ERI, DFT TESTING REVEALED LOW HV IMPEDANCE AND FAILURE TO DELIVER INDUCTION SHOCK. ICD WAS CHANGED OUT AGAIN AND RE-TESTED. DEVICE FAILED TO DELIVER SHOCK AND REGISTERED A LOW IMPEDANCE WARNING. PATIENT WAS EXTERNALLY DEFIBRILLATED. LEAD WAS REPLACED AND SYSTEM TESTED NORMALLY.

    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 64 YR Required Intervention