MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO?; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	K173
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this pacemaker exhibited difficulties to interrogate, as the programmer was unable to locate or identify the implanted device.Technical services (ts) was consulted and provided troubleshooting guidance; however, the issue persisted.The field representative was paged for in-person support.No adverse patient effects were reported.This pacemaker remains in service.
Event or Problem Description
It was reported that this pacemaker exhibited difficulties to interrogate, as the programmer was unable to locate or identify the implanted device.Technical services (ts) was consulted and provided troubleshooting guidance; however, the issue persisted.The field representative was paged for in-person support.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this patient passed away on hospice care from pneumonia.The field representative noted there were no issues related to the device.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of difficult to interrogate/telemetry (wand) was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this pacemaker exhibited difficulties to interrogate, as the programmer was unable to locate or identify the implanted device.Technical services (ts) was consulted and provided troubleshooting guidance; however, the issue persisted.The field representative was paged for in-person support.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this patient passed away on hospice care from pneumonia.The field representative noted there were no issues related to the device.

• Brand Name: INGENIO?
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 24012206
• Report Number: 2124215-2026-01432
• Device Sequence Number: 9343262
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)160821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/11/2026

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: 08/21/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 167493
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 03/10/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/23/2026; 03/11/2026
• Date Device Manufactured: 08/26/2014
• 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: Female