BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6151060 · Received December 7, 2016

    Report

    Report Number
    2938836-2016-15218
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 16, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY AFTER BEING FOUND UNRESPONSIVE. THE PATIENT¿S WIFE CALLED EMS WHO INITIATED CPR, BUT LATER THE PATIENT WAS PRONOUNCED DEAD. THE DEVICE WAS INTERROGATED AND UPON REVIEW OF THE EPISODES, THE DEVICE INITIALLY DETECTED VT HOWEVER THE DEVICE WAS PROGRAMMED TO A VT-1 MONITOR ZONE BETWEEN 160-193 BPM AND THE VT WAS OCCURRING AT 181 BPM. WITHIN 2 MINUTES THE PATIENTS VENTRICULAR RHYTHM HAD DEGENERATED INTO EITHER A LOW AMPLITUDE VF OR AGONAL RHYTHM. THE ERRATIC VENTRICULAR ACTIVITY WAS ALMOST COMPLETELY SENSED APPROPRIATELY BUT IN VERY RARE OCCURRENCES INTERMITTENT UNDERSENSING OCCURRED DUE TO VARIABILITY IN THE EGM AMPLITUDE. SEVERAL MINUTES LATER IT WAS ABLE TO DETECT VF WHICH CAUSED THE DEVICE TO TRIGGER A SINGLE ROUND OF ATP. HOWEVER BEFORE THE DEVICE COULD CHARGE, THE DEGENERATED RHYTHM CAUSED THE DEVICE TO RETURN TO SINUS. THE VENTRICULAR ACTIVITY WAS SO LOW IN AMPLITUDE THAT INTERMITTENT UNDERSENSING OF THE VENTRICULAR ECTOPIC/AGONAL RHYTHM WAS OCCURRING MORE FREQUENTLY. ALL FURTHER EPISODES STILL PRESENT IN THE DEVICE MEMORY AND APPEARED TO SHOW THE DEVICE IN AN ATRIAL PACE - BI-VENTRICULAR PACE RHYTHM WITH APPARENT NON-CAPTURE WHERE IT APPEARS THE PATIENT WAS RECEIVING CPR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802470 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q 4221984

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death