BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3943988 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13403
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 10, 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

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A ROUTINE FOLLOW-UP, LOW, VARIABLE SENSING AND VARIABLE PACING THRESHOLDS WERE NOTED ON THE TRENDS. RECOMMENDED PROGRAMMING CHANGES WERE MADE AND THE PATIENT WILL BE MONITORED WITH REMOTE MONITORING. THE PATIENTS CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422365 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR