BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA

    MDR report key: 1981084 · Received December 31, 2010

    Report

    Report Number
    1981084
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DEVICE LEAD WAS REMOVED FROM THE PATIENT AFTER ONLY BEING A MONTH OLD. IT WAS REPLACED WITH A NEW LEAD AND THE LEAD REMOVED FROM THE PATIENT WAS THEN OBTAINED BY THE DEVICE REPRESENTATIVE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA LEAD, DEFIBRILLATION NVY ST. JUDE MEDICAL 7121Q/58CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES