MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; Implantable Cardioverter Defibrillator (ICD)

Model Number	E141
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system provided inappropriate anti-tachycardia pacing (atp) and delivered more than two inappropriate shocks due to oversensed noise on the non-boston scientific right ventricular (rv) lead.Technical services (ts) recommended a lead evaluation.At this time, no additional adverse patient effects have been reported, and this icd remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system provided inappropriate anti-tachycardia pacing (atp) and delivered more than two inappropriate shocks due to oversensed noise on the non-boston scientific right ventricular (rv) lead.Technical services (ts) recommended a lead evaluation.At this time, no additional adverse patient effects have been reported, and this icd remains in service.Additional information was received that this event exhausted shock therapy.This icd system also exhibited low impedance measurements on the non-boston scientific rv lead.Ts suspected the lead had insulation damage and recommended a lead revision.Additionally, there were inappropriate stored episodes of non-sustained ventricular tachycardia (nsvt) and no therapy events due to oversensed noise.No additional adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
This report is being submitted as additional information was received regarding the details of this event.The description, device codes, and impact codes were updated.This device was not returned for analysis, as it remains implanted and in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 23849948
• Report Number: 2124215-2025-91987
• Device Sequence Number: 15906985
• Product Code: LWP
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2026

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: 10/31/2016
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 127058
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 06/16/2026; 09/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 06/22/2026; 09/08/2026
• Date Device Manufactured: 11/17/2014
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male