BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2902622 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00257
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 6, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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 RELIABILITY LABORATORY TECHNICIAN; ST JUDE MEDICAL (B)(4) RELIABILITY LABORATORY; NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD MEASURING 44.5CM OF THE DISTAL END WAS RETURNED. EXTERNAL INSULATION ABRASION WAS FOUND AT 7.3CM TO 7.6CM FROM THE DISTAL TIP CONSISTENT WITH LEAD FRICTION TO A CALCIFIED STRUCTURE.

    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
    8849 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1560/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1