BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223116 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03750
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 19, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED EVENT OF NOISE COULD NOT BE VERIFIED. A PARTIAL LEAD WAS RETURNED CUT APART AT 47CM FROM THE HELIX END. ANALYS IS NOTED ABRASIONS ON THE OUTER INSULATION FROM THE HELIX END OVER THE RV CABLE LUMEN. THE ABRASION ALSO WORE OPENED THE ETFE INSULATION OF ONE OF THE RV CABLES. HOWEVER, THE DAMAGE FOUND WOULD NOT GENERATE NOISE. ABRASION IS CONSISTENT WITH FRICTION TOO THE ICD CAN. A COMPLETE ANALYSIS COULD NOT BE PERFORMED, AS ONLY A PORTION OF LEAD WAS RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO NOISE.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention