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

Model Number	D142
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the patient with this implantable cardioverter defibrillator (icd) had atrial pacing lead impedance out-of-range condition and atrial tachy response (atr) episodes demonstrating atrial flutter with associated noise.While on the procedure table preparing for a watchman procedure, the patient experienced a cardiac arrest.Device review showed no stored episodes other than the ongoing atrial flutter.A decrease in intrinsic atrial amplitude was also observed at the time of the event; however, the patient had a history of chronic atrial flutter.The device remains in service.No 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: 25563854
• Report Number: 2124215-2026-32888
• Device Sequence Number: 15930431
• Product Code: LWS
• UDI-Device Identifier: 00802526534249
• UDI-Public: (01)00802526534249(17)170401
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• 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
• Report Date (Section B): 08/19/2026

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: 04/01/2017
• Device Model Number: D142
• Device Catalogue Number: D142
• Device Lot Number: 501342
• 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: Not provided
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 04/01/2015
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male