MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Loss of consciousness (2418); Syncope/Fainting (4411)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced syncope that correlated with a ventricular fibrillation (vf) episode stored on this cardiac resynchronization therapy defibrillator (crt-d).Anti-tachycardia pacing (atp) and one 41j shock were delivered, but the arrhythmia appears to have spontaneously converted on its own afterwards.This crt-d remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient experienced syncope that correlated with a ventricular fibrillation (vf) episode stored on this cardiac resynchronization therapy defibrillator (crt-d).Anti-tachycardia pacing (atp) and one 41j shock were delivered, but the arrhythmia appears to have spontaneously converted on its own afterwards.This crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction to e1: switched first and last name, and corrected spelling error.The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient experienced syncope that correlated with a ventricular fibrillation (vf) episode stored on this cardiac resynchronization therapy defibrillator (crt-d).Anti-tachycardia pacing (atp) and one 41j shock were delivered, but the arrhythmia appears to have spontaneously converted on its own afterwards.This crt-d remains in service.No additional adverse patient effects were reported.Additional information received reported that the patient implanted with this crt-d system experienced a loss of consciousness and fell, resulting in a head contusion.Cardiology referred the patient to a electrophysiology specialist and recommended medication changes.This crt-d 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 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22081889
• Report Number: 2124215-2025-33829
• Device Sequence Number: 7866309
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: (01)00802526534539(17)170108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 06/09/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/07/2017
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 476345
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 06/02/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 05/28/2025; 06/09/2025
• Date Device Manufactured: 01/07/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male