BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3220236 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04352
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 30, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP, DECREASED SENSING, INCREASED CAPTURE AND DECREASED PACING LEAD IMPEDANCE WERE OBSERVED. THE PHYSICIAN DECIDED TO PERFORM A FOLLOW UP IN A SHORT TIME TO MONITOR THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321033 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1