BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN

    MDR report key: 7983698 · Received October 19, 2018

    Report

    Report Number
    2124215-2018-18350
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    March 1, 2018
    Report Date
    August 22, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN-SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND OTHER MANUFACTURER RIGHT VENTRICULAR (RV) LEAD HAD SPIKES IN PACING IMPEDANCE THAT WERE HIGH OUT OF RANGE FOR THE PAST FIVE MONTHS. THE THRESHOLDS AND SENSING WERE WITHIN NORMAL LIMITS, AND NO NOISE WAS SEEN THE ELECTROGRAM. THERE WERE NO REPROGRAMMING OPTIONS AVAILABLE, AS THE ICD COULD NOT BE PROGRAMMED UNIPOLAR. THE SYSTEM REMAINS IN-SERVICE, AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED INCREASING THE ALERT LIMIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824624 INOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D141

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 6947| D141| MISMATCH