MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN CRT-D; IMPLANTABLE PACEMAKER

Model Number	N141
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited possible infection.Reportedly, the was patient complained of a large lump at the implant site and stated that the device was somewhat sticking up.As of this time, the crt-d with the right ventricular (rv) lead and left ventricular (lv) lead remains in service.No additional adverse patient effects were reported.

• Brand Name: ENERGEN CRT-D
• Common Device Name: IMPLANTABLE PACEMAKER
• 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: 22116742
• Report Number: 2124215-2025-35541
• Device Sequence Number: 4171709
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: (01)00802526480966(17)140526
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/26/2014
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 103650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/30/2025
• Date Device Manufactured: 05/30/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male