BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3080266 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01025
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION 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 DEMONSTRATED 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 DEVICE WAS UNDERSENSING VENTRICULAR EVENTS. THE PATIENT WAS UNDERGOING DIALYSIS TREATMENT AT THE TIME WHEN, SVT AND NSLN EPISODES WERE STORED DUE TO VF AND PVCS INTERMITTENTLY BEING UNDERSENSED BY THE DISCRIMINATOR CHANNEL. UNERSENSING CONTINUED WHEN A RETURN TO SINUS AND NSLN WAS DETECTED. THE PATIENT REMAINED IN VF AND EVENTUALLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182444 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3267-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death