MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	G140
Medical Device Problem Codes	Over-Sensing (1438); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a signal artifact monitor (sam) event, disabling the respiratory rate trend (rrt) feature.The health care professional (hcp) contacted technical services (ts) and reported that this occurred during a surgical procedure.Ts advised on turning the rrt feature on.No adverse patient effects were reported.This device remains in service.
Additional Manufacturer Narrative
This product remains implanted and in-service.As such, physical analysis has not been conducted in our laboratory.Based on the available information, and in the absence of a product return, the investigation conclusion code no problem detected was selected.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.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 feature unavailable or intermittent 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 with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a signal artifact monitor (sam) event, disabling the respiratory rate trend (rrt) feature.The health care professional (hcp) contacted technical services (ts) and reported that this occurred during a surgical procedure.Ts advised on turning the rrt feature on.No adverse patient effects were reported.This device remains in service.

• Brand Name: INOGEN? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23701190
• Report Number: 2124215-2025-88698
• Device Sequence Number: 10673287
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: (01)00802526534539(17)180215
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/15/2018
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 481739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 03/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female