BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1955257 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00432
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    June 23, 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.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, AN INCREASE IN RV PACING THRESHOLD AND DECREASE IN SENSING WERE OBSERVED. X-RAY SHOWED THAT THE LEAD WAS STILL IN THE SAME POSITION AS IMPLANT. AFTER ONE MONTH, THE MEASUREMENTS WERE WITHIN RANGE. HOWEVER, DURING A SCHEDULED FOLLOW-UP, HIGH THRESHOLDS WERE STILL OBSERVED. AS SUCH, THE LEAD WAS EXPLANTED.

    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 7170Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention