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

Model Number	G141
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439)
Health Effect - Clinical Codes	Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during ventricular tachycardia (vt) ablation the patient experienced a transient loss of capture while programmed in doo mode.Switching to voo improved capture, and function was normal before and after delivery of radiofrequency energy.Technical services discussed the defib detect circuitry, noting its role in truncating pacing during ablation.A representative was present at bedside performing device evaluation, and the patient is not pacemaker dependent.Currently, this product remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that during ventricular tachycardia (vt) ablation the patient experienced a transient loss of capture and pacing inhibition while programmed in doo mode.Switching to voo improved capture, and function was normal before and after delivery of radiofrequency energy.Technical services discussed the defib detect circuitry, noting its role in truncating pacing during ablation.A representative was present at bedside performing device evaluation, and the patient is not pacemaker dependent.Currently, this product remains in service and no adverse patient effects were reported.

• Brand Name: INOGEN? CRT-D
• Common Device Name: 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: 24678912
• Report Number: 2124215-2026-16210
• Device Sequence Number: 13255910
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: (01)00802526534553(17)200823
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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: 08/23/2020
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 129305
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 06/01/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 03/30/2026; 06/03/2026
• Date Device Manufactured: 09/03/2018
• 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: 73 YR
• Patient Sex: Male