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

Model Number	K064
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.The elective replacement indicator (eri) triggered while implanted.The device diagnostics were performed which resulted in gradual power increased over the past year.Furthermore, the device met the criteria for hydrogen induced leaky by pass capacitor.
Event or Problem Description
It was reported that this implantable pacemaker was received by post market quality assurance without a known reason for explant.No 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: 24601712
• Report Number: 2124215-2026-14273
• Device Sequence Number: 12903737
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: (01)00802526516719(17)170209
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2026

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: Other
• Device Expiration Date: 02/09/2017
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 390255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2015
• 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
• Patient Age: 86 YR
• Patient Sex: Female