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); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine generator change procedure, the presenting electrogram (egm) of this cardiac resynchronization therapy defibrillator (crt-d) showed farfield atrial oversensing and undersensing of atrial flutter.Technical services (ts) was contacted and provided programming optimization recommendations.The generator change was completed successfully with the crt-d explanted due to normal battery depletion (nbd) and replaced with a new device and the right atrial (ra) lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50161818
• Report Number: 2124215-2026-42230
• Device Sequence Number: 21484548
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)191117
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/17/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 182454
• 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: 07/16/2026
• Initial Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 12/06/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male