BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1831222 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03507
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THAT THE SENSING COIL WAS FRACTURED CLOSE TO THE CRIMP SLEEVE TO THE CONNECTOR RING AS A RESULT OF FATIGUE. DUE TO INCREASED STRESS AND AN ACCELERATED FATIGUE, OVER TIME THE SENSING COIL FRACTURED. THIS RESULTED IN THE REPORTED OVERSENSING AND HIGH LEAD IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS DUE TO OVERSENSING OF BOTH LEADS. X-RAY REVEALED TWISTED LEADS AND DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER DID NOT PASS A PORTION OF THE RETURNED PRODUCTS TESTING, SUGGESTING A POSSIBLE PERFORMANCE ISSUE.

    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 7122/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1888TC/52, (B)(4)