BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN EL ICD DR

    MDR report key: 21357203 · Received February 11, 2025

    Report

    Report Number
    2124215-2025-07475
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    April 18, 2023
    Report Date
    April 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534270
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED PATIENT CODES E060101 AND E0112 AND IMPACT CODE F22. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF OVERSENSING WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. THE DEVICE REMAINS IMPLANTED AND IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE. THIS REPORT CONTAINS CORRECTION IN SECTION A1 PATIENT IDENTIFIER.

    Additional Manufacturer Narrative · 0

    THIS REPORT CONTAINS CORRECTION IN SECTION A1 PATIENT IDENTIFIER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED OVERSENSING, NOISY SIGNALS AND LOSS OF CAPTURE (LOC). UPON REVIEW OF THE PRESENTING ELECTROGRAM (EGM), TECHNICAL SERVICES (TS) STATED THAT THERE WAS OVERSENSING OF NON-PHYSIOLOGIC ARTIFACTS WITH PERIODS OF NON-CAPTURE. IT WAS NOTED A HOLTER MONITOR WAS PERFORMED AND SHOWED EPISODES OF VENTRICULAR STANDSTILL/ASYSTOLE DUE TO LOSS OF PACING, WITH THE LONGEST EPISODE AT 9 SECONDS. THE PATIENT HAD COMPLAINED OF PERSISTENT DIZZINESS. TS RECOMMENDED TO HAVE THIS PATIENT SEEN IN CLINIC FOR AS SOON AS POSSIBLE TO REVIEW PERFORMANCE FOR BOTH RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) IN REGARDS OF LEAD INTEGRITY AND ALSO RECOMMENDED TROUBLESHOOTING OPTIONS. THIS DEVICE CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED OVERSENSING, NOISY SIGNALS AND LOSS OF CAPTURE (LOC). UPON REVIEW OF THE PRESENTING ELECTROGRAM (EGM), TECHNICAL SERVICES (TS) STATED THAT THERE WAS OVERSENSING OF NON-PHYSIOLOGIC ARTIFACTS WITH PERIODS OF NON-CAPTURE. TS RECOMMENDED TO HAVE THIS PATIENT SEEN IN CLINIC FOR AS SOON AS POSSIBLE TO REVIEW PERFORMANCE FOR BOTH RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) IN REGARDS OF LEAD INTEGRITY AND ALSO RECOMMENDED TROUBLESHOOTING OPTIONS. THIS DEVICE CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED OVERSENSING, NOISY SIGNALS AND LOSS OF CAPTURE (LOC). UPON REVIEW OF THE PRESENTING ELECTROGRAM (EGM), TECHNICAL SERVICES (TS) STATED THAT THERE WAS OVERSENSING OF NON-PHYSIOLOGIC ARTIFACTS WITH PERIODS OF NON-CAPTURE. TS RECOMMENDED TO HAVE THIS PATIENT SEEN IN CLINIC FOR AS SOON AS POSSIBLE TO REVIEW PERFORMANCE FOR BOTH RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) IN REGARDS OF LEAD INTEGRITY AND ALSO RECOMMENDED TROUBLESHOOTING OPTIONS. THIS DEVICE CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390459 INOGEN EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D143 204294 00802526534270

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other