MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	K064
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding product return status.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 operating in safety mode, and the patient was admitted to the hospital for device replacement.Subsequently, the pacemaker was explanted and replaced.No additional adverse patient effects were reported.Product return was requested.

• Brand Name: ADVANTIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 24320219
• Report Number: 2124215-2026-07907
• Device Sequence Number: 9966420
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: (01)00802526516719(17)161015
• 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: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 10/15/2016
• Device Model Number: K064
• Device Catalogue Number: K064
• Device Lot Number: 389731
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 10/15/2014
• 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 Sex: Male