MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; PACEMAKER

Model Number	K063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this pacemaker device called technical services (ts) to report having experienced two syncopal episodes.The patient speculated that the syncope episodes may have been due to the pacemaker battery having been depleted.The pacemaker had been implanted for about ten years and reached end of life (eol).It was reported that a generator replacement procedure was scheduled.Subsequently, the device replacement procedure was performed, and the pacemaker was explanted and successfully replaced with a new device.No additional adverse patient effects were reported.The device was returned to the facility.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient with this pacemaker device called technical services (ts) to report having experienced two syncopal episodes.The patient speculated that the syncope episodes may have been due to the pacemaker battery having been depleted.The pacemaker had been implanted for about ten years and reached end of life (eol).It was reported that a generator replacement procedure was scheduled.Subsequently, the device replacement procedure was performed, and the pacemaker was explanted and successfully replaced with a new device.No additional adverse patient effects were reported.The device was returned to the facility.

• 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: 19556855
• Report Number: 2124215-2024-36819
• Device Sequence Number: 17820504
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: 00802526516702
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 06/04/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 150337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2014
• 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: 67 YR
• Patient Sex: Female