BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1954989 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00412
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 1, 2010
    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 Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD PERFORATED. PATIENT COMPLAINED OF SEVERE CHEST PAIN POST-IMPLANT. PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT. ECHO SUBSEQUENTLY REVEALED A PERICARDIAL EFFUSION. PHYSICIAN STATED THAT THE EFFUSION WAS TOO SMALL AND NOT A TAMPONADE, HENCE, THE LEAD WAS NOT REPOSITIONED AND THE EFFUSION WAS NOT DRAINED. THE LEAD SHOWED NORMAL VALUES. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WILL BE MONITORED NORMALLY.

    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 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization