BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902571 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00307
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 11, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 7.3-9.9CM FROM THE DISTAL TIP. THE SILICONE INSULATION WAS ABRADED AND THE RV CONDUCTOR WAS VISIBLE. OTHER INTERNAL INSULATION ABRASIONS WERE ALSO FOUND AT 7.2- 7.9CM, 11.2-12.2CM, 12.6-12.8CM, 14.2-16.0CM AND 33.4-34.0CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT ALL ABRASION LOCATIONS.

    Description of Event or Problem · 1

    DUE TO INFECTION THE LEAD WAS EXPLANTED. PRIOR TO REMOVAL VIA X-RAY EXTERNALIZED CONDUCTORS WERE NOTED. CHRONICALLY HIGH TRESHOLDS WERE ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8942 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention BIOTRONIKS 340, (B)(4)