MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD DR; Implantable cardioverter defibrillator (ICD)

Model Number	D143
Medical Device Problem Codes	Off-Label Use (1494); Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Use of Device Problem (1670)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was commanded to deliver one burst of anti-tachycardia pacing (atp) for an atrial flutter.This induced a ventricular fibrillation (vf) and then a commanded shock was delivered.Subsequently the physician pressed the abort function button thinking it was meant to deliver a shock.Lastly, a commanded shock was delivered that converted the vf.This device remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN? EL ICD DR
• 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: 24729606
• Report Number: 2124215-2026-17241
• Device Sequence Number: 10265190
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: (01)00802526534263(17)180314
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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: 03/14/2018
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 204167
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 08/25/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male