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

Model Number	K062
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were no field allegations made against the performance of this pacemaker device.The device was explanted and replaced with the reason for replacement reported as normal battery depletion.The device was returned, and device analysis was completed.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Review of the device memory noted no fault codes or resets.Longevity calculations were performed, and an increased rate of power consumption was confirmed.Analysis confirmed this device appeared to be exhibiting behavior consistent with a high current condition associated with the pacemakers low voltage capacitors.This high current condition depleted the devices battery faster than normal.

• Brand Name: ADVANTIO
• Common Device Name: IMPLANTABLE PACEMAKER DEVICE
• 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: 13677598
• Report Number: 2124215-2022-04991
• Device Sequence Number: 20152351
• Product Code: LWP
• UDI-Device Identifier: 00802526516658
• UDI-Public: 00802526516658
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 06/13/2015
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 117410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female