BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2242687 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06135
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 9, 2011
    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
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS FOUND MULTIPLE INSIDE-OUT INSULATION ABRASIONS BETWEEN THE RV AND SVC COILS AND ALSO BELOW THE SVC COIL. IN ONE OF THESE AREAS, THE RE AND RV CABLES WERE ABRADED EXPOSING THE BARE CABLE WIRE AND THE INNER COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEART CATHETERIZATION PROCEDURE, THE PHYSICIAN NOTICED FRAYING OF THE LEAD INSULATION IN THE AREA OF THE TRICUSPID VALVE AND SUBCLAVIAN CRUSH ON THE RIB-CLAVICLE AREA VIA REVIEW OF FLUOROSCOPY. CAPTURE THRESHOLD HAD INCREASE SINCE APRIL. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention