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

Model Number	E140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Twitching (2172); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) had twitching and spasming in torso and patient advocate was unsure if it was from device or if the lead became loose.Boston scientific technical services (ts) referred patient to health care professional (hcp).This device remains in service.Additional information which indicating that this device was explanted.A new device was then implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) had twitching and spasming in torso and patient advocate was unsure if it was from device or if the lead became loose.Boston scientific technical services (ts) referred patient to health care professional (hcp).This device remains in service.Additional information which indicating that this device was explanted.A new device was then implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; 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 no problem detected.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• 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: 24513647
• Report Number: 2124215-2026-12100
• Device Sequence Number: 15894903
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: (01)00802526480713(17)140609
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 06/09/2014
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 104428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 06/12/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male