BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3791144 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10431
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE EPISODES WERE OBSERVED VIA MERLIN.NET TRANSMISSION. NOISE COULD NOT BE REPRODUCED BY ISOMETRICS AND POCKET MANIPULATION. PROGRAMMING CHANGES WERE MADE AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268861 DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7170Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR