BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1073509 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02403
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED HE COMPLAINT WAS VERIFIED. A PARTIAL LEAD 29.1 CM FROM THE PROXIMAL END WAS RETURNED. THE REPORTED LOW IMPEDANCE OF THE HIGH VOLTAGE INTEGRITY CHECK WAS CAUSED BY CONTACT BETWEEN HE ABRADED RV CABLES AND THE ICD CAN. THE LEAD INSULATION WAS ABRADED DUE TO FRICTION TO THE ICD CAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT FOLLOW-UP, LOW IMPEDANCE WAS OBSERVED. DURING LEAD REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO EXPLANT THE LEAD COMPLETELY AND AN ABRASION WAS NOTED ON THE LEAD 12 CM FROM THE CONNECTOR PIN..

    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 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention