MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO?; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	K174
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was explanted due to an unknown product performance issue.This pacemaker was successfully replaced.No additional adverse patient effects were reported.Additional information was received.This pacemaker was explanted due to reverting to safety mode.
Additional Manufacturer Narrative
Additional information added to b5.F10 and h6 updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50793071
• Report Number: 2124215-2026-49502
• Device Sequence Number: 9415638
• Product Code: LWP
• UDI-Device Identifier: 00802526536786
• UDI-Public: (01)00802526536786(17)170224
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 02/24/2017
• Device Model Number: K174
• Device Catalogue Number: K174
• Device Lot Number: 599692
• 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: 08/26/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 02/24/2015
• 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 Age: 65 YR
• Patient Sex: Female