BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1955195 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00392
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    June 29, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED VISUAL INSPECTION FOUND THAT SEVERAL FILARS OF THE SENSING COIL WERE FRACTURED CLOSE TO THE CRIMP SLEEVE TO THE CONNECTOR RING AS A RESULT OF FATIGUE. THIS CAUSED AN INTERMITTENT OPEN CIRCUIT ON THE SENSING COIL.

    Description of Event or Problem · 1

    THIS PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING INTRINSIC ATRIAL ACTIVITY. A FLUOROSCOPY REVEALED THAT THE LEAD APPEARED TO BE IN THE TRICUSPID VALVE AREA WITH THE RING ELECTRODE IN THE RIGHT ATRIUM. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention