BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2890022 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10726
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 14, 2012
    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 MEASURING 43.0CM FROM THE DISTAL LEAD TIP WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 10.0-10.6CM FROM THE LEAD TIP. EXTERNAL AND INTERNAL INSULATION ABRASION WAS FOUND AT 12-13.6CM FROM THE LEAD TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE, EXTERNALIZED CONDUCTORS WERE OBSERVED. TAMPONADE OCCURRED 10 MINUTES AFTER THE EXPLANT PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID. PATIENT CONDITION AFTER THE EVENT WAS GOOD.

    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 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention