BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223633 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03577
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 5, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR RETURN WAS CONFIRMED. THE OUTER INSULATION, THE PACING COIL LUMEN AND THE SENSING CABLE INSULATION WERE DAMAGED AS A RESULT OF AN ABRASION FROM THE INSIDE TO THE OUTSIDE. THE METAL WIRES OF ONE OF THE SENSING CABLES AND THE METAL FILARS OF THE PACING COIL WERE EXPOSED. THE ELECTRICAL MEASUREMENTS INDICATED A SHORT CIRCUIT BETWEEN THE PACING COIL AND THE SENSINNG COIL/CABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL ABORTED THERAPIES DUE TO A SUSPECTED LEAD DAMAGE. THE DISTURBANCE OBSERVED ON THE EGM'S COULD BE PRODUCED BY MOVING THE SHOULDER. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention