BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2962812 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00104
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 12, 2013
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD MEASURING 22.0CM FROM THE CONNECTOR PIN WAS RETURNED. MULTIPLE EXTERNAL INSULATION ABRASIONS WERE FOUND BETWEEN 14.2-16.1CM FROM THE CONNECTOR PIN CONSISTENT WITH FRICTION TO THE ICD CAN. THE SENSING AND RV CONDUCTORS ETFE COATING WERE INTACT AT ALL LOCATIONS. THE RETURNED LEAD EXHIBITED NORMAL CONTINUITY TEST. A COMPLETE ANALYSIS COULD NOT BE PERFORMED WITHOUT RETURN OF THE ENTIRE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 9.5 WEEKS PREGNANT PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP VISIT. LOW HV LEAD IMPEDANCE WAS OBSERVED UPON DEVICE INTERROGATION. THE PHYSICIAN WITH OBGYN CONSULT DECIDED TO CAP AND REPLACE THE LEAD. NO EVIDENCE OF A LEAD ANOMALY WAS SEEN UPON OBSERVATION. THERE WAS NO REPORT OF AN ADVERSE CONSEQUENCE TO THE PATIENT RESULTING FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64959 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR