BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 3903739 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12776
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 WITH THE LEAD TIP MEASURING 46.0CM WAS RETURNED FOR ANALYSIS. INTERNAL INSULATION ABRASIONS WERE NOTED AT 9.5-10.3CM AND 10.2-10.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. NO ELECTRICAL ANOMALIES WERE DETECTED. PATIENT WAS ASYMPTOMATIC. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE FOLLOWING THE EVENT. BASED ON THE REVIEW OF THE X-RAY VIEWS PROVIDED TO ST. JUDE MEDICAL, THE CONDUCTORS DO NOT APPEAR TO BE EXTERNALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379957 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7040/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR