BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 16583917 · Received March 21, 2023

    Report

    Report Number
    2017865-2023-14259
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    March 2, 2023
    Report Date
    May 6, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FIELD EVENTS OF INAPPROPRIATE THERAPY AND PACING ISSUE WERE NOT REPRODUCED IN THE LAB. VISUAL INSPECTION OF THE SEPTUM AND SETSCREW DID NOT REVEAL ANY ANOMALY THAT COULD CONTRIBUTE TO THE REPORTED EVENT. TELEMETRY, IMPEDANCE, SENSING, PACING AND HIGH VOLTAGE (HV) OUTPUT FUNCTIONS OF THE DEVICE WERE TESTED AND FOUND TO BE NORMAL.

    Description of Event or Problem · 0

    MANUFACTURER REPORT NUMBER: 2017865-2023-14261; 2017865-2023-142640. IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS ON (B)(6) 2023 AND SCHEDULED TO RECEIVE PROGRAMMING CHANGES. IT WAS NOTED DURING ROUTINE MEASUREMENTS THAT THE DEFIBRILLATORY IMPEDANCE WAS HIGH AND ABOVE THE NORMAL RANGE. RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD NOISE WAS OBSERVED POST SHOCK FOR VENTRICULAR FIBRILLATION (VF) AND VENTICULAR TACHYCARDIA (VT). AUTOMODE SWITCH EPISODES SHOWED RV LEAD NOISE. THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR COVID. THE RA AND RV LEADS WERE CONFIRMED TO BE FAILING. THE PATIENT WAS STABLE WITH NO ADVERSE REACTIONS WITH LIMITED EXPOSURE DUE TO COVID. THE PATIENT LATER ON UNDERWENT A PROCEDURE TO EXPLANT THE SYSTEM ON (B)(6) 2023. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365421 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000055658 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention