MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	G148
Medical Device Problem Codes	Over-Sensing (1438); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) asking about this cardiac resynchronization therapy defibrillator (crt-d) system.The hcp noted this crt-d exhibited low amplitudes on the right atrial (ra) channel.Ts noted there was not undersensing on the presenting electrogram (egm) but noted there was far-field oversensing.This crt-d remains in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
This device remains in service and was not returned for analysis; 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.

• Brand Name: INOGEN? X4 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: 25333508
• Report Number: 2124215-2026-28891
• Device Sequence Number: 21239822
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)220131
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 05/29/2026

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: 01/31/2022
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 233534
• 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: 05/06/2026
• Initial Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 02/12/2020
• 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: 78 YR
• Patient Sex: Female