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

Model Number	K173
Medical Device Problem Codes	Premature Discharge of Battery (1057); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause.At this time, no further information is available.Should additional information become available this report will be updated.The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this pacemaker was explanted and replaced due to an unspecified product performance issue.No additional adverse patient effects were reported.This pacemaker was returned for analysis.
Event or Problem Description
It was reported that this pacemaker was explanted and replaced due to an unspecified product performance issue.No additional adverse patient effects were reported.This pacemaker was returned for analysis.Additional information received reported that this pacemaker was explanted and replaced due to voltage is too low for projected remaining capacity.No additional adverse patient effects were reported.This pacemaker was returned for analysis.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.

• 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: 24356863
• Report Number: 2124215-2026-08719
• Device Sequence Number: 11999907
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)170226
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2026

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: 02/26/2017
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 398286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Female