BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2984181 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00228
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 3, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    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 A PARTIAL LEAD MEASURING 17.5CM FROM THE CONNECTOR PIN WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 12.5-13.1CM FROM THE CONNECTOR PIN. THE ETFE COATING OF ONE RV CONDUCTOR AND ONE SVC CONDUCTOR WAS ABRADED AT THE SAME LOCATION. A FRACTURE OF THE SVC CONDUCTOR WAS ALSO FOUND AT THIS AREA OF ABRASION. EXTERNAL INSULATION ABRASION WAS FOUND AT 16.5CM FROM THE CONNECTOR PIN. SHORT CIRCUITS WERE IDENTIFIED BETWEEN THE LOW VOLTAGE AND HIGH VOLTAGE PATHS. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING A PATIENT ALERT. INTERROGATION REVEALED LOW LEAD IMPEDANCE. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA X-RAY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86491 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR