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

Model Number	K173
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Attempts to establish telemetry were unsuccessful, and a memory download could not be performed.The device case was then opened to facilitate analysis of the internal components, and visual inspection revealed no irregularities.The battery was separated from the other device electronics, and external power was applied to the hybrid.Hybrid current drain was measured as normal.Analysis determined that the device was unable to perform a memory download due to a performance issue with the battery component.
Event or Problem Description
It was reported that this product was returned with no reported product performance issues or adverse patient effects.Analysis completed in our post market quality assurance laboratory identified a product performance issue.No adverse patient effects were reported.

• 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: 22285469
• Report Number: 2124215-2025-40291
• Device Sequence Number: 20949158
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)160611
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: 06/11/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 161134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2014
• 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
• Patient Sex: Female