BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2242642 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06110
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 28, 2011
    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
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A LEAD ISSUE WAS REPORTED. FLUOROSCOPY FOUND ONE OF THE RV CONDUCTOR CABLES OUTSIDE OF THE LEAD BODY BETWEEN THE RV AND SVC COIL.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT THE LEAD WAS EXPLANTED.

    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 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention