BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE-FIXATION LEAD

    MDR report key: 1073552 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02446
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND DAMAGES ON THE LEAD CONSISTENT WITH THAT CAUSED BY TWIDDLER'S SYNDROME. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. THE CONDITION OF THIS DEVICE WAS NOT FOUND TO BE A RESULT OF DEFICIENCY IN MATERIALS OR WORKMANSHIP.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO TWIDDLER SYNDROME, RESULTING IN LOSS OF SENSING AND HIGH PACING THRESHOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE-FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7022/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention