BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1895604 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04338
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 17, 2010
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS OF THE LEAD FOUND INSULATION ABRASIONS AT 13CM AND 23.3CM FROM THE CONNECTOR PIN. THE CABLES WERE EXPOSED BUT THE EFTE COATING WAS NOT ABRADED. THE INNER INSULATION COATING ON THE CABLES WAS NOT ABRADED. THESE ABRASIONS ARE CONSISTENT WITH THAT OF FRICTION TO THE CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, WHEN VF WAS INDUCED AND (B)(4) DELIVERED, THE DEVICE'S OUTPUT CIRCUITRY WAS DAMAGED DUE TO ARCING. AN INSULATION BREAK WAS OBSERVED DURING THE EXPLANT PROCEDURE.

    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 Required Intervention