BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2242800 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06053
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    July 7, 2011
    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 Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS FOUND AT 30.5-32.5CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. ONE RV CONDUCTOR WAS ALSO MELTED. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF LOW LEAD IMPEDANCE WHEN THE RV CONDUCTOR COMES IN CONTACT WITH THE ICD CAN. ANOTHER EXTERNAL INSULATION ABRASION WAS FOUND AT 29.2-30.2 CM FROM THE DISTAL TIP, CONSISTENT WITH FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A NOTIFICATION DUE TO LOW IMPEDANCE. DEVICE DISPLAYED AN ALERT INDICATING POSSIBLE HV LEAD ISSUE. INSULATION DAMAGE SUSPECTED. LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    NEW INFORMATION STATED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention