BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4820014 · Received June 4, 2015

    Report

    Report Number
    2938836-2015-26677
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 2, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VIBRATORY ALERT FOR HIGH, OUT-OF-RANGE, HV LEAD IMPEDANCE WAS RECEIVED VIA A MERLIN.NET. PATIENT WAS BROUGHT INTO CLINIC AND OUT OF RANG IMPEDANCE WAS CONFIRM DURING IN-CLINIC TESTING. LEAD DAMAGE WAS NOTED VIA IMAGING. THE LEAD WAS EXPLANTED AND REPLACED BUT THE PROBLEM STILL PERSISTED. THE DEVICE WAS ALSO EXPLANTED AND REPLACED, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362370 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120Q/52 4135697

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention (B)(4), 1075411