BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOGEN EL ICD DR

    MDR report key: 22111379 · Received May 29, 2025

    Report

    Report Number
    2124215-2025-35335
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    February 20, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534249
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO H6: DEVICE CODE SIGNAL ARTIFACT A090801 AND USE OF DEVICE PROBLEM A23 WERE REMOVED.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED A FALSE SIGNAL ARTIFACT MONITOR (SAM) EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING FROM A PROCEDURE AT THAT TIME. AS A RESULT, THE RESPIRATORY RATE TREND (RRT) SENSOR WAS DISABLED AND LOW OUT OF RANGE SHOCK AND PACE IMPEDANCE MEASUREMENTS WERE RECORDED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, INCLUDING PROGRAMMING RRT BACK ON. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED A FALSE SIGNAL ARTIFACT MONITOR (SAM) EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING FROM A PROCEDURE AT THAT TIME. AS A RESULT, THE RESPIRATORY RATE TREND (RRT) SENSOR WAS DISABLED AND LOW OUT OF RANGE SHOCK AND PACE IMPEDANCE MEASUREMENTS WERE RECORDED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, INCLUDING PROGRAMMING RRT BACK ON. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36321 INOGEN EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D142 507319 00802526534249

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male