BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 1955214 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00494
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    MANDATORY MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF AN IMPEDANCE ANOMALY WAS CONFIRMED IN THE LABORATORY. BENCH TESTS SHOWED RV TO CAN LEAD IMPEDANCE MEASUREMENTS WERE HIGH. ANALYSIS IDENTIFIED AN ANOMALOUS TRANSISTOR CONNECTION WITHIN THE HYBRID ASSEMBLY AS THE CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXHIBITING INTERMITTENT HIGH HV LEAD IMPEDANCE MEASUREMENTS. THE MEASUREMENTS COULD NOT BE REPRODUCED WITH ISOMETRICS OR POCKET MANIPULATION. BOTH THE DEVICE AND LEAD WERE EXPLANTED. BLOOD WAS FOUND INSIDE THE LEAD AND DEVICE HEADER UPON EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention (B)(4)