BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION LEAD

    MDR report key: 1073090 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02337
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 23, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW SENSING AND HIGH CAPTURE THRESHOLDS WERE OBSERVED. AS SUCH, THE LEAD WAS REPOSITIONED. PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7070/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention