MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? X4 CRT-D; cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G148
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered potential inappropriate therapy for due to atrial undersensing.Technical services (ts) reviewed the stored data and noted the atrial undersensing resulted in the device determined the ventricular rate was greater than the atrial rate, 13 anti-tachycardia pacing (atp) bursts and three electric shocks were delivered, one of the atp bursts accelerated the rhythm to ventricular fibrillation (vf), but the rhythm was ultimately converted.Ts advised evaluation of the atrial lead and recommended reprogramming adjustments.No additional adverse patient effects were reported.This icd remains in service.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50813000
• Report Number: 2124215-2026-49867
• Device Sequence Number: 18819601
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)240426
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 04/26/2024
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 282048
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/10/2022
• 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; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female