BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3781955 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10115
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    February 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT CAPTURE COULD NOT BE ESTABLISHED AFTER SEVERAL POSITIONING ATTEMPTS. THE LEAD WAS NOT IMPLANTED AND WAS REPLACED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258815 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR