BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4852521 · Received June 18, 2015

    Report

    Report Number
    3010215456-2015-00515
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS DISLODGED. THE LEAD WAS REPLACED AND THE PATIENT'S CONDITION WAS GOOD AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396017 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. (CRM-KISTA) 7122Q/58 A000002046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TENDRIL STS (B)(4)