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

Model Number	K173
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory the device case was opened and visual inspection revealed no irregularities.Testing found that the battery had depleted earlier than expected.When connected to an external power source, the device passed all tests and operated normally.No high current drain or other device anomaly was identified during analysis.Although the was caused by a depleted battery, laboratory analysis was unable to reproduce the condition that caused the battery to deplete prematurely.
Event or Problem Description
It was reported that this device was received by post market quality assurance without a known reason for explant.No 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: 22346633
• Report Number: 2124215-2025-42833
• Device Sequence Number: 12893399
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)160613
• 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: 2015
• Device Explanted Year: 2024
• 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): 06/27/2025

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: 06/13/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 161241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2014
• 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