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

Model Number	K063
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Arrhythmia (1721); Pain (1994)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient with this implantable pacemaker experienced chest pains and getting low dose vibrating.Also, patient stated that someone is tampering with the pacemaker, and signal cannot work when having serious episodes.To date, this device remains in service.Additional information indicated that this device was explanted, and a new device was implanted.No adverse patient effects were reported.Additional information from patient stating the device implant was not working as patient had life threatening arrhythmia.Patient experienced heart attacks, and the device did not do anything.Patient has "been having a lot of problems" and the pacemaker has not been "kicking in" or controlling the heartbeat.
Additional Manufacturer Narrative
This supplemental correction report was created to capture update on bsc aware date.
Event or Problem Description
It was reported that patient with this implantable pacemaker experienced chest pains and getting low dose vibrating.Also, patient stated that someone is tampering with the pacemaker, and signal cannot work when having serious episodes.To date, this device remains in service.Additional information indicated that this device was explanted, and a new device was implanted.No adverse patient effects were reported.Additional information from patient stating the device implant was not working as patient had life threatening arrhythmia.Patient experienced heart attacks, and the device did not do anything.Patient has "been having a lot of problems" and the pacemaker has not been "kicking in" or controlling the heartbeat.

• 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: 22039459
• Report Number: 2124215-2025-31855
• Device Sequence Number: 8908871
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: 00802526516702
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 06/09/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 150547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female