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

Model Number	K173
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker and the right ventricular (rv) lead triggered a lead safety switch (lss) due to high out of range pacing impedance measurements.After the lss, there was oversensing of noisy signals in the rv channel.The device was reprogrammed to unipolar pacing and bipolar sensing.It was noted there was a high capture threshold.Also, the device declared explant.The device has been implanted for 11 years and expectations for longevity have been met.Technical services (ts) discussed replacing the rv lead and this pacemaker.This pacemaker remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker and the right ventricular (rv) lead triggered a lead safety switch (lss) due to high out of range pacing impedance measurements.After the lss, there was oversensing of noisy signals in the rv channel.The device was reprogrammed to unipolar pacing and bipolar sensing.It was noted there was a high capture threshold.Also, the device declared explant.The device has been implanted for 11 years and expectations for longevity have been met.Technical services (ts) discussed replacing the rv lead and this pacemaker.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information added to b5.
Event or Problem Description
It was reported that this pacemaker and the right ventricular (rv) lead triggered a lead safety switch (lss) due to high out of range pacing impedance measurements.After the lss, there was oversensing of noisy signals in the rv channel.The device was reprogrammed to unipolar pacing and bipolar sensing.It was noted there was a high capture threshold.Also, the device declared explant.The device has been implanted for 11 years and expectations for longevity have been met.Technical services (ts) discussed replacing the rv lead and this pacemaker.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
New information updated for section e.

• 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: 23200310
• Report Number: 2124215-2025-69714
• Device Sequence Number: 9139204
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)161127
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 11/27/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 392931
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 03/19/2026
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/23/2025; 03/20/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male