MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	E142
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) system presented to the emergency room.An interrogation was performed.It was found this icd had delivered multiple rounds of inappropriate anti-tachycardia pacing and multiple inappropriate shocks due to atrial fibrillation with rapid ventricular response.Therapy was exhausted.Additional information has been requested but was not provided at this time.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
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 the patient with this implantable cardioverter defibrillator (icd) system presented to the emergency room (er).An interrogation was performed.It was found this icd had delivered multiple rounds of inappropriate anti-tachycardia pacing and multiple inappropriate shocks due to atrial fibrillation with rapid ventricular response.Therapy was exhausted.Additional information from the field representative provided the patient was admitted after presenting to the er.A cardioversion was completed and medication adjusted.Reprogramming was completed.No further inappropriate shocks have been reported.This icd remains in service.No additional adverse patient effects were reported.

• Brand Name: ENERGEN? ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 24333549
• Report Number: 2124215-2026-08257
• Device Sequence Number: 13200245
• Product Code: LWP
• UDI-Device Identifier: 00802526480737
• UDI-Public: (01)00802526480737(17)150726
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 07/26/2015
• Device Model Number: E142
• Device Catalogue Number: E142
• Device Lot Number: 112041
• 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: 01/31/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 07/31/2013
• 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; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male