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

Model Number	K173
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient with this pacemaker stated that their remote communicator displayed a red call doctor icon.The patient subsequently presented to their clinic, where the device was explanted and replaced two days later.At this time, the reason for the alert is unknown, as no data had been received from the communicator for approximately one year due to connection issues.It was also observed that a yellow alert had been stored before for atrial intrinsic amplitude out of range.The device has not been returned for analysis.No additional adverse effects were reported.
Event or Problem Description
It was reported that the patient with this pacemaker stated that their remote communicator displayed a red call doctor icon.The patient subsequently presented to their clinic, where the device was explanted and replaced two days later.At this time, the reason for the alert is unknown, as no data had been received from the communicator for approximately one year due to connection issues.It was also observed that a yellow alert had been stored before for atrial intrinsic amplitude out of range.The device has not been returned for analysis.No additional adverse effects were reported.Additional information was received from the field.The reason for the alert observed was related to the time stated to be one year approximately were there was no communication between the device and the communicator.Subsequently, this device was then explanted for normal battery depletion (nbd).
Additional Manufacturer Narrative
Supplemental correction report due to information received from the field stating the reason for the alert and explant as a result of normal battery depletion (nbd).If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 23154605
• Report Number: 2124215-2025-68004
• Device Sequence Number: 5217858
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: (01)00802526516825(17)160721
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 07/21/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 164023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/07/2025
• Date Device Manufactured: 07/23/2014
• 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 Age: 85 YR
• Patient Sex: Male