BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION

    MDR report key: 1954898 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00430
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 8, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    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.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED DUE TO CHEST-PAIN. A HIGH CAPTURE THRESHOLD AND LOW SENSING WERE OBSERVED. UNDER FLUOROSCOPY, THE LEAD SEEMED TO HAVE MOVED INTO THE PERICARDIUM. THE LEAD WAS EXPLANTED. THE PHYSICIAN BELIEVED THAT THE LEAD ADVANCEMENT INTO THE PERICARDIAC. TISSUE WAS DUE TO THE PATIENT'S CARDIOMYOPATHY AND THAT THE EVENT WAS NOT CAUSED BY THE LEAD.

    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 58 YR Required Intervention