BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1010619 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01200
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 20, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS NOTED AN INSULATION ABRASION AT 52CM FROM THE CONNECTOR TIP, EXPOSING THE RV CABLE INSULATION. NO METAL CABLE EXPOSURE WAS OBSERVED. THE LOCATION OF THIS ABRASION IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH ANOTHER DEVICE. X-RAY AND SEM ANALYSIS REVEALED A FRACTURE TO THE DISTAL COIL AT THE WELDED AREA ADJACENT TO THE HELIX. THIS COULD HAVE CONTRIBUTED TO THE REPORTED NOISE AND SENSING RESULTING IN INAPPROPRIATE THERAPIES. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    AFTER THE INITIAL REPOSITION IN (B) (6) 2007, THE PATIENT REPORTED CHEST PAIN. THE LEAD WAS FOUND TO HAVE FALLEN INTO THE SAME HOLE AS THE INITIAL PERFORATION, CAUSING ANOTHER PERFORATION. THE LEAD WAS EXPLANTED AND REPLACED WITH A PASSIVE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7022/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention