BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 1895664 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04460
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 24, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT WAS CONFIRMED IN THE LABORATORY. AS RECEIVED, THE LEAD WAS CUT INTO TWO SECTIONS. VISUAL INSPECTION NOTED MULTIPLE ABRASIONS ON THE OUTSIDE OF THE INSULATION AND FROM THE INSIDE-OUT. THE OUTSIDE ABRASIONS ARE CHARACTERISTIC OF LEAD FRICTION TO THE ICD CAN.

    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 RIGHT VENTRICULAR LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7041/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention