BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210669 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03276
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 7, 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 EXTERNAL INSULATION ABRASION WAS NOTED AT 6.5-7.0CM FROM THE CONNECTOR PIN. THE COIL WAS MELTED AND FRACTURED AT THE SAME LOCATION. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 9.0-12.9CM FROM THE LEAD TIP. INTERNAL INSULATION ABRASION WAS NOTED AT 19.7-20.6CM FROM THE LEAD TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED EXTERNALIZED CONDUCTORS WERE OBSERVED VIA A FLUOROSCOPY. THE LEAD WAS REPLACED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309548 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