BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3090136 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01084
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 27, 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

    EXTERNAL INSULATION ABRASION WAS NOTED AT 7.1-7.2CM FROM THE DISTAL TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. INTERNAL INSULATION ABRASION WAS NOTED AT 13.1-14.2CM AND 32.0-32.3CM FROM THE DISTAL TIP ELECTRODE. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 7.0-7.1CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THE LEAD WAS PREVIOUSLY CAPPED DUE TO NOISE AND INCREASED THRESHOLD. RECENTLY, NON-SUSTAINED EVENTS WERE NOTED AND PHYSICIAN DECIDED TO EXTRACT THE LEADS. FLUOROSCOPY WAS PERFORMED AND EXTERNALIZED CONDUCTORS BETWEEN THE RV AND SVC COIL WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191729 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention