BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1050772 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01724
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 2, 2007
    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 Location
    GA
    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 UPON INTERROGATION, THE DEVICE REPORTED THAT THE HV LEAD IMPEDANCE WAS HIGH AND POSSIBLE OUTPUT DAMAGE WAS DETECTED. THE DEVICE WAS REMOVED AND THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention