BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 11979576 · Received June 10, 2021

    Report

    Report Number
    2017865-2021-20178
    Event Type
    Death
    Date Received
    June 10, 2021
    Date of Event
    May 27, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ABBOTT
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING VENTRICULAR FIBRILLATION (VF) IN A NON-CLINICAL ENVIRONMENT. THE DEVICE DIAGNOSED THE VF AND CHARGED TO DELIVER THERAPY; HOWEVER THE VF SIGNAL HAD A LOW AMPLITUDE, WHICH CONTINUED TO DECREASE, RESULTING IN UNDERSENSING BY THE DEVICE AS THE AMPLITUDE WAS BELOW PROGRAMMED DETECTION. THIS RESULTED IN THE DEVICE DIAGNOSING A RETURN TO SINUS RHYTHM AND HIGH VOLTAGE THERAPY WAS NOT DELIVERED. THE VF RESULTED IN THE DEATH OF THE PATIENT. TECHNICAL SUPPORT REVIEWED THE SESSION RECORDS AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE DEVICE BEHAVED AS EXPECTED, FOR THE RESULTING SIGNALS OF A DYING HEART, BASED ON THE PROGRAMMED SETTINGS. THERE WAS NO KNOWN CORONER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872371 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ABBOTT CD3371-40 4740506

    Patients

    Seq Age Sex Outcome Treatment
    1 Death