MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PACEMAKER

Model Number	K173
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient experienced a syncopal event.The patient had performed a patient-initiated interrogation.Upon review of the device data, it was noted that the device reached elective replacement indicator (eri) and atrial undersensing was also observed.Atrial sensitivity settings may be considered for programming optimization.Successful rv automatic pace threshold test and the most recent lead tests are within normal limits.Currently, this product remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this patient experienced a syncopal event.The patient had performed a patient-initiated interrogation.Upon review of the device data, it was noted that the device reached elective replacement indicator (eri) and atrial undersensing was also observed.Atrial sensitivity settings may be considered for programming optimization.Successful rv automatic pace threshold test and the most recent lead tests are within normal limits.Subsequently, a revision procedure was performed and the device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INGENIO
• Common Device Name: 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: 22935425
• Report Number: 2124215-2025-61294
• Device Sequence Number: 9878596
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)160627
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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): 11/24/2025

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: 06/27/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 162284
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 07/02/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 82 YR
• Patient Sex: Male