BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1073544 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02438
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 22, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED OVERSENSING OF NOISE. THE NOISE DID NOT APPEAR TO BE PHYSIOLOGIC. THE PATIENT WAS ASYMPTOMATIC.

    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 7030/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1