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

Model Number	K064
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) exhibited difficulties to interrogate this pacemaker.Technical services (ts) reviewed the device and performed multiple data and provided troubleshooting steps, including rebooting the programmer and adjusting the telemetry wand positioning; however, the device could not be read.The healthcare provider was transferred to the local representative for further assistance.No adverse patient effects were reported.This pacemaker remains in service.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25833731
• Report Number: 2124215-2026-38135
• Device Sequence Number: 10411859
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: (01)00802526516719(17)170223
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: 02/23/2017
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 390381
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 02/23/2015
• 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: 75 YR
• Patient Sex: Male