MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO?; IMPLANTABLE PACEMAKER

Model Number	K173
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this pacemaker recorded code 1003, which states that the voltage is too low for projected remaining capacity.Technical services (ts) suspected there was battery depletion.Ts recommended the field representative send in device data to provide a replacement window.It was noted the patient was in bradycardia.The physician referred the patient to electrophysiology (ep).This pacemaker remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker recorded code 1003, which states that the voltage is too low for projected remaining capacity.Technical services (ts) suspected there was battery depletion.Ts recommended the field representative send in device data to provide a replacement window.It was noted the patient was in bradycardia.The physician referred the patient to electrophysiology (ep).This pacemaker remains in service.No adverse patient effects were reported.Additional information was received.At discretion of the patient's family, they have decided to not replace this pacemaker due to the patient's age, dementia, and lack of mobility.
Additional Manufacturer Narrative
Additional information added to b5 and e1.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: INGENIO?
• 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: 25017833
• Report Number: 2124215-2026-22829
• Device Sequence Number: 10294879
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)161127
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/27/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 392996
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 06/10/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/12/2026; 06/11/2026
• Date Device Manufactured: 11/27/2014
• 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
• Patient Sex: Male