BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220291 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04219
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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. EXTERNAL INSULATION ABRASION WAS NOTED AT 55.3-55.5CM FROM THE CONNECTOR PIN, CONSISTENT WITH FRICTION TO ANOTHER DEVICE. THE ETFE COATING WAS INTACT AT THE SAME LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PATIENTS LAST FOLLOW-UP VISITS, AN INCREASE IN IMPEDANCE AND THRESHOLD WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED DURING DEVICE ERI CHANGEOUT. DURING EXPLANT PROCEDURE, THE LEAD WAS BROKEN AND THE DISTAL PART BECAME STUCK INSIDE THE SUBCLAVIAN VEIN BUT WAS LATER COMPLETELY EXPLANTED. THE DISTAL PART OF THE LEAD WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321302 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1