BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN X4 CRT-D

    MDR report key: 9270047 · Received November 2, 2019

    Report

    Report Number
    2124215-2019-23261
    Event Type
    Malfunction
    Date Received
    November 2, 2019
    Date of Event
    November 4, 2016
    Report Date
    November 2, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON DATA ANALYSIS OF (3) MODEL G148 DEVICES, (2) RED ALERT (SHOCK LEAD IMPEDANCE OUT OF RANGE) AND (3) YELLOW ALERT (ACCELERATED ARRHYTHMIA EPISODE (VENTRICULAR). THE ALERT DATES OCCURRED FROM NOVEMBER 4, 2016 THROUGH JANUARY 13, 2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOSTON SCIENTIFIC IMAGINEIF TEAM CONDUCTED A RETROSPECTIVE DATA ANALYSIS (LATITUDE IMAGINEIF DATA STUDY (PHASE 2)). BASED ON DATA ANALYSIS, FOLLOW-UP PATIENT POPULATIONS WERE STRATIFIED INTO TWO GROUPS WITH A GOAL TO DETERMINE WHICH PATIENTS COULD BE FOLLOWED REMOTELY (COMPUTER-BASED HEALTH CARE) VERSUS THOSE PATIENTS THAT MAY REQUIRE IN-CLINIC FOLLOW-UP. DATA FROM 20,000 (5000 ICDS, 5000 PACEMAKERS, 5000 CRT-P AND 5000 CRT-D) DEVICES IMPLANTED IN THE UNITED STATES WAS COLLECTED USING LATITUDE NXT AND DE-IDENTIFIED FOR ANALYSIS. ALL DATA WAS USED IN ACCORDANCE WITH PATIENT CONFIDENTIALITY LAWS, REGULATIONS, AND DATA USE AGREEMENTS. A LISTING OF POSSIBLE MALFUNCTIONS OR PRODUCT DEFICIENCIES THAT WOULD SATISFY THE DEFINITION OF A COMPLAINT WERE SENT TO THE COMPLAINT MANAGEMENT CENTER (CMC) FOR FURTHER PROCESSING. RED ALERTS FROM THE PATIENT LATITUDE MONITORING ARE DEVICE CONDITIONS THAT COULD POTENTIALLY LEAVE THE PATIENT WITHOUT AVAILABLE DEVICE THERAPY. EACH INDIVIDUAL RED ALERT NEEDS TO BE ASSESSED BY THE CLINICIAN OR PHYSICIAN. YELLOW ALERTS ARE DECLARED WHEN A CERTAIN DEVICE CONDITION OR PATIENT HEART-HEALTH ISSUE IS DETECTED THAT MAY WARRANT CLINICIAN REVIEW OR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064125 INOGEN X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G148

    Patients

    Seq Age Sex Outcome Treatment
    1