BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 2242554 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06345
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    July 4, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POOR SENSING VALUES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention