BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1955157 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00198
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 12, 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
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE CLINIC WITH 5 NON-SUSTAINED VF EPISODES, WHICH LOOKED LIKE NOISE. PHYSICIAN ELECTED TO CAP THE LEAD. FLUOROSCOPY DURING LEAD REPLACEMENT REVEALED PRONOUNCED ANGLE AT LEAD TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention