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

Model Number	K064
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Syncope/Fainting (4411); Asystole (4442)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker exhibited a 20 second pause when the patient had a seizure.The device was showing less than 3 months of longevity remaining.Technical services (ts) recommended device replacement, and the pacemaker was reprogrammed to prevent entering safety mode.Subsequently, this device was explanted and replaced.This pacemaker has not been received for investigation.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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 24913619
• Report Number: 2124215-2026-20969
• Device Sequence Number: 9196063
• Product Code: LWP
• UDI-Device Identifier: 00802526516719
• UDI-Public: (01)00802526516719(17)170218
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: K064
• Device Catalogue Number: K064
• Device Lot Number: 390360
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2026
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 73 YR
• Patient Sex: Female