BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4173926 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16684
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST-IMPLANT FOLLOW-UP, POCKET INFECTION WAS OBSERVED. THE PATIENT WAS TREATED WITH ANTIBIOTICS THAT WERE NOT SUCCESSFUL. THE SYSTEM WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655318 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD LDA220Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention CD3365-40Q,7107940,2088/(B)(4),1458Q/(B)(4)