BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2984231 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00242
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 6.5-10.3CM AND 15.5-18.2CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 5.0-5.8CM. INTERNAL INSULATION ABRASIONS WERE NOTED AT 6.0-6.6CM AND 9.5-11.0CM FROM THE DISTAL TIP. THE ETFE COATING WAS DAMAGED AT 6.0-6.6CM FROM THE DISTAL TIP CONSISTENT WITH EXPLANT DAMAGE. INTERNAL INSULATION ABRASIONS WERE NOTED AT 15.3-16.5CM AND 20.1-20.5CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH VOLTAGE LEAD IMPEDANCE WAS LOW. LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85893 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR