MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? X4 CRT-D; Defibrillator, Automatic Implantable Cardioverter, With Crt-D

Model Number	G146
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that electrogram (egm) review was requested for this cardiac resynchronization therapy defibrillator (crt-d) due to observed pauses less than two seconds.Upon review, each pause was preceded by an atrial fibrillation (af) beat.When atrial flutter response (afr) is triggered, post-ventricular atrial refractory period (pvarp) is extended and the ventricular pace (vp) cannot track the p-wave.This appears related to farfield oversensing marked as premature atrial contraction (pac), just prior.Technical services (ts) discussed troubleshooting options and programming considerations, recommending extending the blanking from smart to fixed and turning off afr.Additional information received reported that the recommended programming changes were completed.This crt-d remains in service, and will continue to be monitored.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: INOGEN? X4 CRT-D
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50748339
• Report Number: 2124215-2026-48849
• Device Sequence Number: 15589138
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2026

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: 08/29/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 371219
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 08/29/2015
• 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 Sex: Female