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

Model Number	K273
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Bradycardia (1751); Syncope/Fainting (4411)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient with this pacemaker presented in a syncopal state.The heart rate went down.The pacemaker was requested to be interrogated and remains in service at this time.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination noted scratches on the case and header.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient with this pacemaker presented in a syncopal state.The heart rate went down.The pacemaker was requested to be interrogated.At this time the pacemaker has been explanted and returned for analysis without any additional allegations and after being implanted for several years.No additional adverse patient effects were reported.

• Brand Name: VITALIO
• 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: 16698848
• Report Number: 2124215-2023-16320
• Device Sequence Number: 20234949
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 02/26/2017
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 406814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2015
• 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: Other
• Patient Sex: Male