BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 3220321 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04455
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    January 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE FOUND LOW HV LEAD IMPEDANCE AND IDENTIFIED AN ANOMALOUS COMPONENT WITHIN THE HYBRID CIRCUITRY. THIS WOULD ACCOUNT FOR THE OUTPUT DAMAGE ALERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT PROCEDURE, THE DEVICE WAS INTERROGATED WHILE IN THE BOX. UPON INTERROGATION, AN ERROR MESSAGE INDICATING POSSIBLE OUTPUT CIRCUIT DAMAGE WAS OBSERVED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321331 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR