BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 12636181 · Received October 14, 2021

    Report

    Report Number
    2017865-2021-32772
    Event Type
    Death
    Date Received
    October 14, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ABBOTT
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF UNDERSENSING WAS CONFIRMED VIA REVIEW OF EGMS. A REVIEW OF THE SESSION RECORDS BY ABBOTT TECHNICAL SUPPORT INDICATED THERE WAS NO MALFUNCTION OF THE LEADS OR DEVICE AND THAT THEY WERE WORKING AS PROGRAMMED. TECHNICAL SUPPORT DID CONFIRM HERE IS SOME UNDERSENSING DUE TO THE NATURE OF THE SENSIBILITY ALGORITHM AND THE SIGNALS ARE VERY SMALL, BUT DID NOT CAUSING DELAY TO THERAPY INITIALLY. THERE WAS A RETURN TO SINUS BECAUSE OF THE SMALL SIGNALS AND THEN RATE HAS DETERIORATED, CONSISTENT WITH AN AGONAL RHYTHM. INTERROGATION OF THE DEVICE REVEALED THE DEVICE WAS ABOVE THE ELECTIVE REPLACEMENT INDICATOR WHEN RECEIVED. PACING, SENSING, IMPEDANCE, HIGH-VOLTAGE (HV) OUTPUT, AND PATIENT NOTIFIER WERE ALL TESTED AND NO ANOMALIES WERE DETECTED. NO DEVICE MALFUNCTION WAS NOTED DURING TESTING AND THE CAUSE OF THE FIELD EVENT WAS UNDETERMINED.

    Description of Event or Problem · 0

    FURTHER INFORMATION FROM THE FIELD INDICATED THERE WAS NO ALLEGATION OF ANY MALFUNCTION OF THE LEADS.

    Description of Event or Problem · 1

    DURING A REMOTE FOLLOW-UP, THE PATIENT EXPIRED DUE TO AN UNKNOWN CAUSE. UPON INVESTIGATION, INADEQUATE HIGH VOLTAGE (HV) OUTPUT AND FUNCTIONAL UNDERSENSING WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND DETERMINED THE DEVICE WAS PERFORMING AS PROGRAMMED. THERE IS NO ALLEGATION THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529165 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ABBOTT CD3371-40QC A000071372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death