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

Model Number	D141
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that electrogram (egm) review was requested for this implantable cardioverter defibrillator (icd) system due to inappropriate tachy therapy.Egm review revealed that supraventricular tachycardia (svt) became uncorrelated due to an artefact observed on the shock channel, and anti-tachycardia pacing (atp) and single shock were delivered.The rhythm did not change, and the second shock was diverted.This icd remains in service.No additional 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.
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.
Event or Problem Description
It was reported that electrogram (egm) review was requested for this implantable cardioverter defibrillator (icd) system due to inappropriate tachy therapy.Egm review revealed that supraventricular tachycardia (svt) became uncorrelated due to an artefact observed on the shock channel, and anti-tachycardia pacing (atp) and single shock were delivered.The rhythm did not change, and the second shock was diverted.This icd remains in service.No additional adverse patient effects were reported.Additional information received reported that the patient implanted with this implantable cardioverter defibrillator (icd) system was scheduled for a virtual follow-up appointment in (b)(6) 2026.This icd system remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN? EL ICD VR
• Common Device Name: IMPLANTABLE DEVICE
• 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: 24907109
• Report Number: 2124215-2026-20839
• Device Sequence Number: 9827493
• Product Code: LWS
• UDI-Device Identifier: 00802526534225
• UDI-Public: (01)00802526534225(17)170108
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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: 01/07/2017
• Device Model Number: D141
• Device Catalogue Number: D141
• Device Lot Number: 188260
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 06/03/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/03/2026; 06/04/2026
• 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
• Patient Age: 57 YR
• Patient Sex: Female