BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION LEAD

    MDR report key: 1073171 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02528
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT WAS RECEIVED WITH THE RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND THE OUTER INSULATION ABRASION AT 12.1 CM FROM THE PIN OVER THE SVC CABLE LUMEN, POSSIBLY CAUSED BY FRICTION WITH THE ICD CAN. NO ABRASIONS WERE FOUND INSIDE THE LUMEN.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVICE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1