BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION

    MDR report key: 1955208 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00429
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 10, 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 THE REPORTED FIELD EVENT WAS CONFIRMED IN THE LABORATORY. VISUAL ANALYSIS FOUND THE OPTIM SHEATH DAMAGED AT SEVERAL AREAS. ELECTRICAL ANALYSIS FOUND AN OPEN CIRCUIT OF THE INNER COIL CLOSE TO THE LEAD TIP. THE INNER COIL WAS BENT AND THE SILICONE PART AND PTFE INSULATION WERE DEFORMED, INDICATING THAT THE LEAD TIP WAS BENT. THE FRACTURED AREA APPEARED TO BE CAUSED BY FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP, NO CAPTURE THRESHOLD WAS NOTED. THE R-WAVE HAD DECREASED AND THE LEAD IMPEDANCE HAD INCREASED. THE PATIENT FELT A VIBRATORY ALERT. IT WAS REPORTED THAT THE PATIENT HAD FALLEN IN (B)(6), 2010. UNDER FLUOROSCOPY, THERE WERE NO SIGNS OF A MICROSCOPIC FRACTURE AND THE LEAD APPEARED TO BE IN THE SAME POSITION. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7170/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention