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

Model Number	K063
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery of this implantable pacemaker dropped from 2.5 years to 8 months in a span of 9 months.Also, non-sustained episodes appeared to be alerting almost daily.A request was made to have data from this device analyzed.Data analysis confirmed that the battery appeared to be depleting normally.Furthermore, the longevity has exceeded expectations as the battery was outperforming the nominal model.The labeled replacement recommendations of the device apply.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Revision to fields e1 initial reporter first name and e1 initial reporter email.This supplemental report has been created to capture additional information and information correction.
Event or Problem Description
It was reported that the battery of this implantable pacemaker dropped from 2.5 years to 8 months in a span of 9 months.Also, non-sustained episodes appeared to be alerting almost daily.A request was made to have data from this device analyzed.Data analysis confirmed that the battery appeared to be depleting normally.Furthermore, the longevity has exceeded expectations as the battery was outperforming the nominal model.The labeled replacement recommendations of the device apply.This device remains in service.No adverse patient effects were reported.Additional information indicated that this device was explanted and replaced with a new device.No additional adverse patient effects were reported.

• Brand Name: ADVANTIO
• Common Device Name: IMPLANTABLE 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: 22791326
• Report Number: 2124215-2025-56403
• Device Sequence Number: 8643384
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)170218
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 02/18/2017
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 393755
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 02/18/2015
• 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: 80 YR
• Patient Sex: Female