BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1831083 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03227
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 23, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASION WAS FOUND AT 8.5-8.7CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO THE ICD. THE RING ELECTRODE COIL WAS EXPOSED AT THE ABRASION SITE. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTED THAT THE LEAD WAS CAPPED DUE TO OVERSENSING.

    Description of Event or Problem · 1

    AN EPISODE WAS RECORDED SHOWING NON-PHYSIOLOGIC NOISE ON THE RV LEAD. THE NOISE WAS NOT REPRODUCED WITH POCKET MANIPULATION. THE PHYSICIAN CHOSE TO REPROGRAM THE DEVICE AND MONITOR THE PATIENT. HOWEVER, THE PROGRAMMING DOES NOT RESOLVE THE LEAD PROBLEM. NO CHANGE TO THE LEAD SYSTEM IS SCHEDULED AT THIS TIME.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention