BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3781974 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09918
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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: A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 48.5CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH CAPTURE THRESHOLD AND LOW SENSING WERE OBSERVED. UPON OPENING THE POCKET, TWIDDLER SYNDROME WAS NOTED AND IS BELIEVED TO HAVE CAUSED LEAD DISLODGEMENT. THE PATIENTS CONDITION WAS FINE AND THERE WERE NO ADVERSE CONSEQUENCES DUE TO THE EVENT. THE LEAD WAS CUT, CAPPED, AND A PORTION EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259418 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention