MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? X4 CRT-D; Implantable cardioverter defibrillator (ICD)

Model Number	G148
Medical Device Problem Codes	High impedance (1291); Data Problem (3196); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) showed a flat egm for the non boston scientific left ventricular (lv) lead channel.This device had 44% right ventricular (rv) pacing and 100% lv pacing, and the lv lead was programmed to subthreshold measurement of 0.1v.The lv lead also exhibited intermittently high, out-of-range pace impedance measurements greater than 3,000 ohms, and the patient commented that the lv lead may have dislodged.However, it was unclear why biventricular (biv) was still programmed, while the lv was programmed subthreshold.The previous lv threshold measurement was 5v.This crt-d remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause/resolution and initial reporter contact details.At this time, no further information is available.Should additional information become available this report will be updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: INOGEN? X4 CRT-D
• Common Device Name: Implantable cardioverter defibrillator (ICD)
• 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 ; +1(651)582-6168
• MDR Report Key: 25617526
• Report Number: 2124215-2026-33798
• Device Sequence Number: 9012276
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)170108
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2026

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: 01/08/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 128723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/25/2026; Not provided
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 06/25/2026; 09/04/2026
• Date Device Manufactured: 01/08/2015
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male