BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 2962834 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00130
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL ANALYSES INDICATE THERE IS NO SIGNIFICANT DIFFERENCE IN THE OCCURRENCE OF UNDERSENSING BETWEEN THE LOW FREQUENCY ATTENUATION (LFA) FILTER USED IN THESE DEVICES AND THE TACHY FILTER USED IN EARLIER GENERATION DEVICES. REVIEW OF STORED ELECTROGRAMS FROM SPECIFIC EPISODES CONTAINING UNDERSENSING DEMONSTRATES LOW AMPLITUDE SIGNALS THAT ARE NOT SENSED DUE TO AMPLITUDES BEING BELOW THE PROGRAMMED SENSITIVITY THRESHOLD OF THE DEVICE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AND UNDERSENSING OF VF WAS SUSPECTED. REVIEW OF EGMS SHOWED THAT VF WAS VERY FINE AT THE TIME OF DEATH. IT WAS ALSO NOTED THAT THERE WAS NO ATRIAL ACTIVITY AND IT WAS SUSPECTED THAT THE PATIENT'S HEART FUNCTION MAY HAVE NEARLY STOPPED AT THE TIME VF WAS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64459 UNIFY ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3261-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death