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

Model Number	G146
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
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 health care professional (hcp) requested review of the presenting electrogram stored by the cardiac resynchronization therapy defibrillator (crt-d) system.Technical services (ts) reviewed per request.Ts advised there is intermittent loss of capture on the left ventricular channel.The hcp provided the patient would be seen in the clinic for an evaluation.Additional information has been requested but was not provided at this time.This crt-d remains in service.No adverse patient effects were reported.
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 health care professional (hcp) requested review of the presenting electrogram stored by the cardiac resynchronization therapy defibrillator (crt-d) system.Technical services (ts) reviewed per request.Ts advised there is intermittent loss of capture on the left ventricular (lv) channel.The hcp provided the patient would be seen in the clinic for an evaluation.Additional information from the field representative provided the patient was subsequently seen in clinic.Reprogramming was completed.During reprogramming in some configurations the patient experienced phrenic nerve stimulation.This crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN? X4 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22440540
• Report Number: 2124215-2025-45446
• Device Sequence Number: 11939194
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: (01)00802526534577(17)170826
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 08/26/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 371168
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 08/26/2015
• 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 Age: 80 YR
• Patient Sex: Male