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

Model Number	K062
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	10/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker exhibited failure to capture and high out of range pacing impedance measurements on the right ventricular channel.Due to this, a lead safety switch was triggered.It was determined that this was due to a right ventricular lead fracture.Furthermore, the patient experienced a bradycardia episode.A procedure was performed in order to surgically abandon and replace the lead.During this procedure it was decided to also replace the device.No further adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker exhibited failure to capture and high out of range pacing impedance measurements on the right ventricular channel.Due to this, a lead safety switch was triggered.It was determined that this was due to a right ventricular lead fracture.Furthermore, the patient experienced a bradycardia episode.A procedure was performed in order to surgically abandon and replace the lead.During this procedure it was decided to also replace the device.This device was returned to boston scientific for analysis.No further adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was corrected from the following fields: d6b: explant date.
Event or Problem Description
It was reported that this implantable pacemaker exhibited failure to capture and high out of range pacing impedance measurements on the right ventricular channel.Due to this, a lead safety switch was triggered.It was determined that this was due to a right ventricular lead fracture.Furthermore, the patient experienced a bradycardia episode.A procedure was performed in order to surgically abandon and replace the lead.During this procedure it was decided to also replace the device.This device was returned to boston scientific for analysis.No further adverse patient effects were reported.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15820824
• Report Number: 2124215-2022-47796
• Device Sequence Number: 20022246
• 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: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2023

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: 12/06/2014
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 114824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 01/18/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/01/2022; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2012
• 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: 75 YR
• Patient Sex: Male