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

Model Number	K063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information regarding this event.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this pacemaker was explanted due to an unspecified other observation/complication.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker was explanted due to an unspecified other observation/complication.No additional adverse patient effects were reported.Additional information from the field indicates this device was removed at the physicians discretion in order for the patient to have a magnetic resonance imaging (mri) conditional system implanted, were previously it was not, due to the use of non boston scientific leads.No adverse patient effects were reported.
Additional Manufacturer Narrative
This event is no longer reportable since additional information from the field indicates this device was removed at the physicians discretion in order for the patient to have a magnetic resonance imaging (mri) conditional system implanted, were previously it was not, due to the use of non boston scientific leads.

• 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: 21919022
• Report Number: 2124215-2025-26853
• Device Sequence Number: 21031723
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)160105
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 05/01/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 149037
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/05/2025
• Date Device Manufactured: 06/20/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female