BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223444 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03648
    Event Type
    Malfunction
    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
    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 RELIABILITY LABORATORY TECHNICIAN E3-NOT APPLICABLE. JUDE MEDICAL CRMD RELIABILITY LABORATORY NO COMPLAINT WAS RECEIVED WITH THE RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. A PARTIAL LEAD WAS RETURNED FOR EVALUATION. AN OUTER INSULATION ABRASION WAS OBSERVED AT 16.3 CM TO 16.8 CM FROM THE PINS OVER THE RING CABLE LUMEN. THE ABRAASION WAS CAUSED BY FRICTION TO THE ICD CAN. THE ETFE INSULATION OF THE RING CABLES WERE NOT ABRADED.

    Description of Event or Problem · 1

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

    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 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1