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

Model Number	K063
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Defective Device (2588); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Communication to the device could not be established with a programmer.The device case was then opened to facilitate analysis of the internal components and visual inspection revealed no irregularities.The battery was separated from the other device electronics and external power was applied to the hybrid.Hybrid current drain measured normal.Analysis determined that the battery depleted prematurely due to a performance anomaly with the battery component.
Event or Problem Description
It was reported that this pacemaker exhibited noise and oversensing in the right ventricular (rv) channel.This noise reoccurred while the patient was sitting in the chair.Possible reprogramming was discussed.A review of another episode noted possible loss of capture.Subsequently, the rv lead exhibited pacing inhibition and high capture thresholds, this lead was surgically abandoned and successfully replaced.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received; this pacemaker was explanted due to normal battery depletion and successfully replaced.This pacemaker was later returned for analysis.No adverse patient effects were reported.

• 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: 22358419
• Report Number: 2124215-2025-43144
• Device Sequence Number: 8655367
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)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: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 11/12/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 391095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2014
• 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: 78 YR
• Patient Sex: Male