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

Model Number	K063
Medical Device Problem Codes	Battery Problem (2885); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker showed an elective replacement indicator (eri) up to 3 months before the end of life (eol).Technical services (ts) discussed that the patient stated that the device traveled up to the collar bone.Ts added that will continue to follow up with health care professional (hcp) and the surgery will place a new device under the muscle.This pacemaker remains in service.No adverse patient effects were reported.Additional information received indicates that this pacemaker was explanted.A new device with a different model was successfully implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker showed an elective replacement indicator (eri) up to 3 months before the end of life (eol).The patient stated that the device traveled up to the collar bone.Boston scientific technical services (ts) added that will continue to follow up with health care professional (hcp) and the surgery will place a new device under the muscle.This pacemaker remains in service.No adverse patient effects were reported.Additional information received indicates that this pacemaker was explanted.A new device with a different model was successfully implanted.Additionally, the physician stated that the device had not migrated.The device will be returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.
Event or Problem Description
It was reported that this implantable pacemaker showed an elective replacement indicator (eri) up to 3 months before the end of life (eol).The patient stated that the device traveled up to the collar bone.Boston scientific technical services (ts) added that will continue to follow up with health care professional (hcp) and the surgery will place a new device under the muscle.This pacemaker remains in service.No adverse patient effects were reported.Additional information received indicates that this pacemaker was explanted.A new device with a different model was successfully implanted.Additionally, the physician stated that the device had not migrated.The device will be returned for analysis.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: 22751805
• Report Number: 2124215-2025-55451
• Device Sequence Number: 8716157
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)161113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

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: 11/13/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 391187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 01/16/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/16/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2014
• 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: 72 YR
• Patient Sex: Female