BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3943982 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13532
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 4, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 53.0CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 42.8-43.1CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION. (B)(6).

    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
    422363 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7031/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1