BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210493 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03278
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    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 EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WAS NOTED AT 12.0-14.0CM AND 28.0CM TO 30.5CM FROM THE DISTAL END. EXTERNALIZED CONDUCTORS DUE TO INTERNAL AND EXTERNAL INSULATION ABRASION WAS NOTED AT 11.5-14.0CM FROM THE DISTAL END. INTERNAL AND EXTERNAL INSULATION ABRASION WAS NOTED AT 8.6-9.2CM FROM THE DISTAL END. THE ETFE COATING WAS INTACT AT ALL ABRASION LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA X-RAY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311119 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention