MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO?; Implantable Pacemaker

Model Number	K174
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Codes	Discomfort (2330); Loss of consciousness (2418)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated during a routine visit.Additionally, the patient felt unwell and experienced a seizure during this visit.Technical services (ts) was consulted and determined that elective replacement indicator had triggered months prior and that the device was likely at end of life status.Ts noted no device interrogation was completed as the local field representative aided staff in helping the patient to the ambulance.The local field representative confirmed that the patient was hospitalized.No additional adverse patient effects were reported.This pacemaker remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50208528
• Report Number: 2124215-2026-42891
• Device Sequence Number: 10274157
• Product Code: LWP
• UDI-Device Identifier: 00802526536786
• UDI-Public: (01)00802526536786(17)160211
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 02/11/2016
• Device Model Number: K174
• Device Catalogue Number: K174
• Device Lot Number: 113111
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 02/18/2014
• 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: Hospitalization
• Patient Sex: Female