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

Model Number	K173
Medical Device Problem Codes	Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited low right ventricular (rv) pace impedance measurements of less than 200 ohms at a generation change procedure.Technical services (ts) reviewed device data and noted that there was myopotential oversensing on the rv channel indicative of insulation failure and recommended lead revision.The physician chose to not replace the lead at this time.This pacemaker was explanted and replaced due to normal battery depletion.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited low right ventricular (rv) pace impedance measurements of less than 200 ohms at a generation change procedure.Technical services (ts) reviewed device data and noted that there was myopotential oversensing on the rv channel indicative of insulation failure and recommended lead revision.The physician chose to not replace the lead at this time.This pacemaker was explanted and replaced due to normal battery depletion.No adverse patient effects were reported.
Additional Manufacturer Narrative
This pacemaker was thoroughly inspected and analyzed upon receipt.Visual inspection of the pacemaker case and header noted no anomalies.The device was cut open and internal visual inspection noted no anomalies.Review of memory noted no suspicious fault codes or resets.It was confirmed that this device experienced normal battery depletion.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 pacing impedance low out of range 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, boston scientific has assigned an investigation conclusion code of no problem detected.

• 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: 22375253
• Report Number: 2124215-2025-43669
• Device Sequence Number: 8017051
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)160925
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 09/25/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 183600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2014
• 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 Age: 85 YR
• Patient Sex: Male