BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1830606 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03385
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEAD POSITIONING THE SUTURE SLEEVE MIGRATED DOWN THE LEAD ENTERING THE VEIN. THE PATIENT WAS TAKEN TO THE VASCULAR LAB FOR THE SUTURE SLEEVE TO BE RETRIEVED. THE IMPLANTING CONSULTANT COMMENTED THAT THIS WAS NOT A LEAD ISSUE BUT A CARELESS MISTAKE BY THE IMPLANTING REGISTRAR. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention