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

Model Number	K172
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Asystole (4442)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was replaced due to normal battery depletion.During the procedure, when the pulse generator was removed from the implant pocket, the system with a right ventricular (rv) lead demonstrated pacing inhibition, loss of capture, noise, oversensing and mv oversensing.As a troubleshooting step, the rv lead was switched to a pacing system analyzer.The patient is pacemaker-dependent and experienced a brief episode of asystole and a cardiac arrest.Technical services confirmed that, for this patient, mv oversensing can be associated typically with high impedance scenarios, and in this case, noise was observed while the pulse generator was outside the implant pocket, suggesting a possible lead-to-header contact issue during manipulation.The device was explanted and successfully replaced, and no additional adverse patient effects were reported.The product has not been returned for analysis.The rv lead remains in service.
Event or Problem Description
It was reported that this pacemaker was replaced due to normal battery depletion.During the procedure, when the pulse generator was removed from the implant pocket, the system with a right ventricular (rv) lead demonstrated pacing inhibition, loss of capture, noise, oversensing and mv oversensing.As a troubleshooting step, the rv lead was switched to a pacing system analyzer.The patient is pacemaker-dependent and experienced a brief episode of asystole and a cardiac arrest.Technical services confirmed that, for this patient, mv oversensing can be associated typically with high impedance scenarios, and in this case, noise was observed while the pulse generator was outside the implant pocket, suggesting a possible lead-to-header contact issue during manipulation.The device was explanted and successfully replaced, and no additional adverse patient effects were reported.The product has not been returned for analysis.The rv lead remains in service.Additional information indicated that a lead leakage fault was recorded.This fault indicates that the pulse generator (pg) detected external energy on the device, when lead leakage is detected, the system triggers an interrupt that opens the pg lead switches, allowing the hardware to protect itself against potential damage from external sources, this is a normal protection mechanism and not due to any known malfunction.

• Brand Name: INGENIO?
• Common Device Name: IMPLANTABLE 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: 23597134
• Report Number: 2124215-2025-84679
• Device Sequence Number: 10380151
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: (01)00802526516818(17)161214
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 12/14/2016
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 488764
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 12/14/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male