BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION LEAD

    MDR report key: 1073545 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02439
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 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

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS REPOSITIONED AFTER PATIENT REPRESENTED TO THE CLINIC WITH LOW R-WAVES AND HIGH THRESHOLDS. A MICRO- DISLODGEMENT WAS SUSPECTED.

    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