BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3881106 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02253
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 23, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY THE MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT FOR A HIGH, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE. THE LEAD WAS PLANNED TO BE TESTED DURING A DEVICE CHANGE OUT FOR NORMAL BATTERY DEPLETION. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31161 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL INC., CRMD 7120/65

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR