BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 2243001 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06302
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    June 27, 2011
    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 Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    LEAD FRACTURE WAS NOTED 27.1CM FROM THE CONNECTOR PIN. THE INNER COIL AND ONE OF THE SVC CABLES WERE FRACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS NOTED WITH ARM MOVEMENT. LEAD ISSUE SUSPECTED. SYSTEM WAS EXPLANTED AND REPLACED.

    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 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention