BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3884835 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12151
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP, NOISE WAS NOTED. NOISE WAS REPRODUCED WITH ARM MOVEMENTS AND INHIBITION OF PACING WAS OBSERVED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES AND PATIENT IS DOING WELL AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360172 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention