BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830834 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03274
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 13, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Product Problem
    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 THE IMPEDANCE MEASUREMENTS FOR THE RV LEAD HAD INCREASED. RECOMMENDED TESTING THE LEAD WITH ISOMETRICS, ARM POSITIONING AND POCKET MANIPULATION. THE PATIENT WAS ON VACATION AND BELIEVED TO HAVE RETURNED HOME. FURTHER FOLLOW-UP CANNOT BE PERFORMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR