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

Model Number	K062
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited oversensing of a minute ventilation (mv) artifact on the right ventricular (rv) channel.The oversensing lead to pacing inhibition of roughly 2 seconds.Signal artifact monitoring (sam) stored an episode of this event and disabled the mv feature.A review of the reports note loss of capture, as well.Technical services (ts) provided possible causes of this issue and provided resolution recommendations.The device remains in use.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited oversensing of a minute ventilation (mv) artifact on the right ventricular (rv) channel.The oversensing lead to pacing inhibition of roughly 2 seconds.Signal artifact monitoring (sam) stored an episode of this event and disabled the mv feature.A review of the reports note loss of capture, as well.Technical services (ts) provided possible causes of this issue and provided resolution recommendations.The device remains in use.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information, determined this device exhibited oversensing of noise generated by the minute ventilation (mv) sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.

• 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: 16961191
• Report Number: 2124215-2023-25092
• Device Sequence Number: 5244089
• Product Code: LWP
• UDI-Device Identifier: 00802526516658
• UDI-Public: 00802526516658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 12/16/2016
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 390324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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: 85 YR
• Patient Sex: Female