BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3953294 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13559
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 10.4-10.7CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. EXTERNAL INSULATION ABRASION WAS NOTED AT 40.4-40.5CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE SUTURE SLEEVE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. RELIABILITY LABORATORY TECHNICIAN. ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431269 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1