BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901366 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12619
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 5, 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.EXTERNAL INSULATION ABRASION WAS NOTED AT 45.4-45.6CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASION WAS NOTED AT 13.4-14.5CM AND 15.5-17.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS DAMAGED DURING THE SURGICAL PROCEDURE AT THESE LOCATIONS.(B)(4).

    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
    380938 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1