BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 2984252 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00402
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    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 21.8CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 19.4-20.9CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS ABRADED AT THE SAME LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, EXTERNALIZED CONDUCTORS, HIGH PACING LEAD IMPEDANCE AND LOSS OF CAPTURE WERE OBSERVED. THE LEAD WAS CAPPED AND REPLACED. THE PROXIMAL PORTION OF THE LEAD WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87598 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR