MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D141
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Use of Device Problem (1670); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited noise oversensing in the right ventricular (rv) lead channel as well as a signal artifact monitor (sam) episode, which led to the disablement of the respiratory rate trend feature.Technical services (ts) was consulted and upon review noted a low out of range pacing impedance measurement below 200 ohms.Ts advised on programming options and x-ray examination.This system remains in service.No adverse patient effects were reported.

• Brand Name: INOGEN? EL ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER 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: 24973936
• Report Number: 2124215-2026-22227
• Device Sequence Number: 10456174
• Product Code: LWS
• UDI-Device Identifier: 00802526534225
• UDI-Public: (01)00802526534225(17)171204
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• 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): 06/18/2026

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: 12/04/2017
• Device Model Number: D141
• Device Catalogue Number: D141
• Device Lot Number: 193260
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 12/15/2015
• 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: 66 YR
• Patient Sex: Female