BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1050854 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01801
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 30, 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 Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD MEASURING 49.0CM WAS RETURNED IN TWO SEGMENTS. EXTERNAL INSULATION ABRASION WAS NOTED AT 12.7-12.9CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASION WAS NOTED AT 7.3-7.9CM AND 10.2-10.7CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS NOTED AT 12.0-12.9CM FROM THE DISTAL TIP. THE ETFE COATING OF ONE SENSING CONDUCTOR CABLE AND ONE RV CONDUCTOR CABLE WAS ABRADED AT THIS LOCATION. THE INNER COIL WAS EXPOSED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE VENTRICULAR PACE/SENSE CHANNEL, WHICH INHIBITED PACING. IT IS NOTED THAT THE PATIENT IS PACER DEPENDENT. THE NOISE WAS REPRODUCIBLE WITH ISOMETRICS. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE LEAD WAS CAPPED IN 2008. DURING THE REPLACEMENT PROCEDURE FOR THE NEW LEAD IMPLANTED IN 2008, INSULATION ABRASION WAS SEEN ON THIS LEAD. THE LEAD WAS EXPLANTED.

    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