MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO?; IMPLANTABLE PACEMAKER

Model Number	K062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Urinary Tract Infection (2120)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was part of a system revision due to a urinary tract infection and the device was near depletion.There were no additional adverse effects were reported.The pacemaker was explanted.
Event or Problem Description
It was reported that this pacemaker was part of a system revision due to a urinary tract infection and the device was near depletion.There were no additional adverse effects were reported.The pacemaker was explanted.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the device was not confirmed.The device was analyzed, passed all the baseline tests and exhibited normal device functions.A risk review was completed and confirmed that the event of infection was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23660817
• Report Number: 2124215-2025-87084
• Device Sequence Number: 15721373
• Product Code: LWP
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/18/2017
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 390765
• Date Returned to Manufacturer: 11/21/2025
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 06/16/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Male