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

Model Number	K063
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that review was requested of the data from this pacemaker system.Technical services (ts) analyzed device episode data and found many ventricular episodes due to oversensing of myopotential noise on the right ventricular (rv) lead channel for the past four years.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.
Event or Problem Description
It was reported that review was requested of the data from this pacemaker system.Technical services (ts) analyzed device episode data and found many ventricular episodes due to oversensing of myopotential noise on the right ventricular (rv) lead channel for the past four years.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information, there was an alert for out of range shock lead impedance values.Technical services (ts) noted that the values were less than 200 ohms.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.

• 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: 21356541
• Report Number: 2124215-2025-07444
• Device Sequence Number: 7741125
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: 00802526516702
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: Lay User/Patient
• Device Expiration Date: 06/24/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 151476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 06/28/2014
• 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
• Patient Age: 75 YR
• Patient Sex: Male