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

Model Number	K172
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient thinks his heart rate is driven up when his continuous positive airway pressure (cpap) is in use.A boston scientific technical services consultant discussed the clinical observations and precautions with this patient.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.The device was exposed to simulated heart load conditions, and the pacing and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.This device operated as expected during laboratory analysis and the associated investigation determined that this device appeared to exhibit an increase in the pacing rate as a result of the minute ventilation (mv) sensor response to instances where the minute ventilation (mv) sensor did not respond as expected at higher rates.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this patient thinks his heart rate is driven up when his continuous positive airway pressure (cpap) is in use.A boston scientific technical services consultant discussed the clinical observations and precautions with this patient.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.It was reported that this device was subsequently explanted due to normal battery depletion.No adverse patient effects were reported.

• 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: 8420665
• Report Number: 2124215-2019-00643
• Device Sequence Number: 19415128
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: (01)00802526516818(17)160123
• 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: 2024
• 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): 06/06/2025

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: 01/23/2016
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 119491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2014
• 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: 80 YR
• Patient Sex: Male