BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6175346 · Received December 15, 2016

    Report

    Report Number
    2938836-2016-17525
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED ATRIAL STIMULATION DURING PACING TEST DUE TO DISLODGEMENT OF THE VENTRICULAR LEAD. IT WAS CONFIRMED BY THE X-RAYS. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826166 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122Q/65 A000018704

    Patients

    Seq Age Sex Outcome Treatment
    1 Other