BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830765 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03286
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 8, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    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

    ADDITIONAL INFORMATION SHOWS LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW SENSING, INCREASED THRESHOLDS AND HIGH IMPEDANCE VALUES WERE OBSERVED. THE LEAD WAS EXPLANTED.

    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 1582/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention