MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	K274
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It wats reported that patient initiated interrogation (pii) of this pacemaker was unsuccessful, and the last successful device transmission was nearly 1.5 months ago.A device evaluation from (b)(6) 2026 revealed a battery longevity estimate of 1.5 years remained at that time.While troubleshooting the communicator interrogation issue, the patient's landline connection was replaced with a cellular adapter, and piis were attempted in the bedroom and living room.During these attempts, two to three collecting waves were observed.A request was made to have remote monitoring data from this device analyzed.Based on the multiple pii attempts, it was suspected that the device had exceeded the weekly maximum of piis.It was later confirmed that environmental interference had occurred that day of pii attempts.The next day, successful communicator interrogation revealed that the pacemaker was operating in safety mode.Programmer interrogation confirmed the device was operating as programmed and there was 1.5 years remaining on the battery.The following month, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.Product return was requested.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding product return status.At this time, no further information is available.Should additional information become available this report will be updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: VITALIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 25526647
• Report Number: 2124215-2026-32195
• Device Sequence Number: 10746685
• Product Code: LWP
• UDI-Device Identifier: 00802526536557
• UDI-Public: (01)00802526536557(17)160622
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 06/22/2016
• Device Model Number: K274
• Device Catalogue Number: K274
• Device Lot Number: 100614
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 06/26/2014
• 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 Sex: Female