BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1895685 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04513
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 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 Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AT ONE YEAR FOLLOW-UP, HIGH THRESHOLD WAS OBSERVED. X-RAY REVEALED A PROBABLE MICRO-DISLODGEMENT ON THE RA AND RV LEADS. THE RA LEAD WAS REPOSITIONED, AND THE RV LEAD WAS EXPLANTED AFTER 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/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention (B)(4)