BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3914624 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13132
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP. DECREASED SENSING AND INCREASED CAPTURE THRESHOLD WERE OBSERVED. THE PATIENT WILL BE MONITORED CLOSELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390916 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR