BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 2902564 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00395
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    October 29, 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 Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND AND THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT, THE PATIENT EXPERIENCED CHEST PAIN. A LEAD PERFORATION WITH PERICARDIAL EFFUSION WAS OBSERVED VIA ECHO. WHEN REPOSITIONING WAS UNSUCCESSFUL, THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8757 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention