BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4770078 · Received May 13, 2015

    Report

    Report Number
    2938836-2015-06019
    Event Type
    Injury
    Date Received
    May 13, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 1, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERFORATION HAD OCCURRED DURING THE IMPLANT PROCEDURE. THE LEAD WAS REPOSITIONED. THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314018 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7121Q/65 4605919

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention