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

Model Number	G148
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The device 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.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing and a lower biventricular pacing percentage.Technical services (ts) assessed the pacemaker mediated tachycardia episode and confirmed the oversensing; however, after review of the presenting electrogram, determined the lower biventricular pacing percentage was due to premature ventricular contractions.The field representative increased the sensitivity of the device and will continue to monitor.No adverse patient effects were reported.This crt-d remains in service.

• Brand Name: INOGEN? X4 CRT-D
• Common Device Name: IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 25349229
• Report Number: 2124215-2026-29113
• Device Sequence Number: 18723634
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)210129
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 01/29/2021
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 208406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 02/08/2019
• 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: 75 YR
• Patient Sex: Male