BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION

    MDR report key: 6226868 · Received January 5, 2017

    Report

    Report Number
    2938836-2017-00371
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 3, 2016
    Report Date
    December 3, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, VENTRICULAR FIBRILLATION WAS NOTED POTENTIALLY CAUSED BY P WAVE OVERSENSING DUE TO THE RIGHT VENTRICULAR LEAD COUNTING THE P WAVES AND R WAVES. THE LEAD WAS CAPPED AND REPLACED DURING AN ELECTIVE DEVICE REPLACEMENT AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10400 DURATA STS OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. 7170/65 2912731

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention