MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number	K172
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested from the field.If additional information is received, this report will be updated.
Event or Problem Description
It was reported that this pacemaker recorded ventricular tachycardia (vt) episodes, and the health care professional (hcp) questioned if the episodes were true or due to noise.Technical services (ts) reviewed the episodes and noted that recent episodes appeared to be true vt; however, there were previous episodes with small signals on the right ventricular (rv) channel being oversensed and causing pacing inhibition of approximately 13 seconds.The patient was asymptomatic.Troubleshooting options were discussed with the hcp, and they noted the patient would be enrolled in remote monitoring.No adverse patient effects were reported.The device remains in service.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that this pacemaker recorded ventricular tachycardia (vt) episodes, and the health care professional (hcp) questioned if the episodes were true or due to noise.Technical services (ts) reviewed the episodes and noted that recent episodes appeared to be true vt; however, there were previous episodes with small signals on the right ventricular (rv) channel being oversensed and causing pacing inhibition of approximately 13 seconds.The patient was asymptomatic.Troubleshooting options were discussed with the health care professional (hcp), and they noted the patient would be enrolled in remote monitoring.No adverse patient effects were reported.This device was explanted due to normal battery depletion.No additional adverse patient effects were reported.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• 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: 10723316
• Report Number: 2124215-2020-21473
• Device Sequence Number: 14406474
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: 00802526516818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 06/27/2025

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: 07/17/2016
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 122332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2014
• 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 Age: 84 YR
• Patient Sex: Male