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

Model Number	K063
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been received for analysis however analysis has not yet started.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this device had evidence of undersensing on the stored atrial intracardiac electrogram.Technical services (ts) recommended device optimization for the patient.No adverse patient effects were reported.The device remains implanted and in service.New information received indicates that this device was explanted nine months later for normal battery depletion.The device was returned 19 months post explant for evaluation.

• Brand Name: ADVANTIO?
• 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: 22211452
• Report Number: 2124215-2025-39391
• Device Sequence Number: 15486977
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)160311
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 03/11/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 147091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female