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

Model Number	K064
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Bradycardia (1751); Syncope/Fainting (4411)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient with this pacemaker experienced a syncopal episode.The device was found to be in safety mode; because of this, the device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
The patient with this pacemaker experienced a syncopal episode.This patient experienced bradycardia.The device was found to be in safety mode; because of this, the device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ADVANTIO?
• 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: 24410963
• Report Number: 2124215-2026-09746
• Device Sequence Number: 10577402
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: (01)00802526516719(17)160822
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 08/22/2016
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 112995
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/22/2026
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 08/26/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female