BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 2902600 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00404
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    September 15, 2012
    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

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    TWO DAYS POST IMPLANT, PATIENT WAS ADMITTED TO HOSPITAL WITH CHEST PAIN AND SHORTNESS OF BREATH. ECHO REVEALED A SMALL PERICARDIAL EFFUSION. PATIENT WAS DISCHARGED. TWO WEEKS LATER, THE PATIENT RETURNED TO HOSPITAL WITH CHEST PAIN. NOTICEABLE EFFUSION OBSERVED VIA ECHO. THRESHOLDS SHOWED AN INCREASE. A PERICARDIOCENTESIS WAS PERFORMED. LEAD REMAINS IMPLANTED AND PATIENT'S CONDITION WILL BE MONITORED. THE PHYSICIAN WAS UNCERTAIN WHICH LEAD CAUSED THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8686 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention