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

Model Number	E143
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) system developed a large hematoma after falling and sustaining an impact to the device.Subsequently, the patient underwent revision surgery to address the hematoma at the icd implantation site.During this procedure, the icd, along with the right atrial (ra) and right ventricular (rv) leads, were surgically abandoned, and the system was not replaced.The ra lead is a non-boston scientific device.No additional adverse patient effects were reported.This icd has not been received for analysis.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) system developed a large hematoma after falling and sustaining an impact to the device.Subsequently, the patient underwent revision surgery to address the hematoma at the icd implantation site.During this procedure, the icd, along with the right atrial (ra) and right ventricular (rv) leads, were surgically abandoned, and the system was not replaced.The ra lead is a non-boston scientific device.No additional adverse patient effects were reported.This icd has not been received for analysis.Additional information was received indicating that this icd was explanted due to an infection.No additional adverse patient effects were reported.This icd has not been received for analysis.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21749132
• Report Number: 2124215-2025-20242
• Device Sequence Number: 9492006
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: (01)00802526480744(17)150530
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 05/30/2015
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 108205
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/01/2025
• Date Device Manufactured: 06/07/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Male