BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073143 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02385
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 5, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    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 THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED LEAD PERFORATION. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND WAS FOUND TO BE WITHIN SPECIFICATION. MECHANICAL AND VISUAL INSPECTION FOUND THE HELIX IN FULLY EXTENDED POSITION AND CLOGGED WITH BODY FLUID/TISSUE, PREVENTING IT FROM RETRACTING. THE ENSUING RESISTANCE MAY HAVE RESULTED IN AN OVER-TORQUE CONDITION. AFTER DESTRUCTIVE ANALYSIS AND CLEANING, THE HELIX WAS FOUND TO FUNCTION NORMALLY.

    Description of Event or Problem · 1

    ECHO AND X-RAY REVEALED THAT THE LEAD HAD PERFORATED THE RIGHT VENTRICLE. THE LEAD WAS EXPLANTED AND REPLACED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention