MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; PACEMAKER

Model Number	K062
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker recorded noise that was oversensed as well as loss of capture (loc) on the right ventricular (rv) lead channel.The associated right ventricular (rv) lead is a non-boston scientific and technical services (ts) recommended troubleshooting to assess lead integrity.No adverse patient effects were reported.This pacemaker remains in service.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.
Event or Problem Description
It was reported that this pacemaker recorded noise that was oversensed as well as loss of capture (loc) on the right ventricular (rv) lead channel.The associated right ventricular (rv) lead is a non-boston scientific device, and technical services (ts) recommended troubleshooting to assess lead integrity.No adverse patient effects were reported.This pacemaker remains in service.Additional information was received that this pacemaker was succesfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.This product has not been returned.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20451654
• Report Number: 2124215-2024-64316
• Device Sequence Number: 7110286
• Product Code: LWP
• UDI-Device Identifier: 00802526516658
• UDI-Public: 00802526516658
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/06/2025

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: 10/28/2016
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 389901
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 10/28/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female