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

Model Number	K274
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was explanted due to an unknown product performance anomaly.A new device was implanted successfully.No additional adverse patient effects were reported.Additional information was received that indicated the device had reached elective replacement indicator (eri) status and the explant was an elective procedure.No additional adverse patient effects were reported.The device was retained by the hospital.
Additional Manufacturer Narrative
Amendment to previous report: further additional information provided, reported that the device was explanted after it had reached elective replacement indicator (eri) status.No report of performance issues or adverse effects.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this pacemaker was explanted due to an unknown product performance anomaly.A new device was implanted successfully.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
On 04/28/2026, the local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: VITALIO?
• 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: 25030087
• Report Number: 2124215-2026-23073
• Device Sequence Number: 10127014
• Product Code: LWP
• UDI-Device Identifier: 00802526536557
• UDI-Public: (01)00802526536557(17)160812
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 08/12/2016
• Device Model Number: K274
• Device Catalogue Number: K274
• Device Lot Number: 100764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/11/2026
• Date Device Manufactured: 08/27/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female