MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO?; PACEMAKER

Model Number	K173
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Asystole (4442)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker reverted to safety mode, and the patient experienced syncope and a ten second asystole due to pacing inhibition.Technical services (ts) discussed unipolar pacing and sensing.A device replacement was recommended.This pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.This product has not returned for analysis.
Event or Problem Description
It was reported that this pacemaker reverted to safety mode, and the patient experienced syncope and a ten second asystole due to pacing inhibition.Technical services (ts) discussed unipolar pacing and sensing.A device replacement was recommended.This pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.This product was returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination identified no anomalies.The device was confirmed to be operating in safety mode.Review of stored memory found the device appropriately moved to safety mode after detecting three errors within 48 hours.Analysis of battery performance identified a performance issue with the battery component a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of device displays error message was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, the conclusion code cause traced to component failure was selected.

• Brand Name: INGENIO?
• Common Device Name: PACEMAKER
• 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: 23067463
• Report Number: 2124215-2025-65093
• Device Sequence Number: 21343166
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)170108
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 01/08/2017
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 394413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2015
• 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; Other; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male