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

Model Number	E140
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Under-Sensing (1661)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.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 the patient implanted with this implantable cardioverter defibrillator (icd) system presented to the emergency room (er) due to cardiac arrest.Additionally, the device clock did not appear to have adjusted to daylight savings time.Electrogram (egm) review revealed ventricular fibrillation (vf) undersensing, instances where the arrhythmia was below the rate cutoff (rco), and anti-tachycardia pacing (atp) was ineffective.Technical services (ts) discussed troubleshooting options and programming considerations; the patient was referred to cardiology for the clinical decision of arrhythmia interpretation and next steps.This icd remains in service.No additional adverse patient effects were reported.

• Brand Name: ENERGEN? ICD
• 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 PR ; PR
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25589176
• Report Number: 2124215-2026-33264
• Device Sequence Number: 10318817
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: (01)00802526480713(17)160919
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 09/19/2016
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 118202
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 09/28/2014
• 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: Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male