BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION

    MDR report key: 1050921 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01860
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    THE REPORTED NOISE ANOMALY WAS CONFIRMED. EXAMINATION OF THE LEAD REVEALED THAT ALL FOUR FILARS OF THE DISTAL COIL WERE FRACTURED AT 64.8CM FROM THE CONNECTOR END, ADJACENT TO THE DISTAL TIP. THE FRACTURE RESULTED IN INTERMITTENT OPEN IMPEDANCE. THIS WOULD ACCOUNT FOR THE NOISE ISSUE REPORTED FROM THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE EGMS. THE NOISE APPEARED TO BE AN INSULATION BREAK. HIGH IMPEDANCE WAS ALSO NOTED. THE LEAD WAS REPLACED.

    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 PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7071/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention