BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3903777 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12752
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 23, 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. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER SEVERAL ATTEMPTS AT REPOSITIONING, A GOOD SIGNAL AMPLITUDE AND A GOOD THRESHOLD COULD NOT BE OBTAINED. THE LEAD WAS REPLACED. THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380916 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1