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

Model Number	K273
Medical Device Problem Codes	Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Health Effect - Clinical Codes	Bradycardia (1751); Loss of consciousness (2418); Syncope/Fainting (4411)
Date of Event	12/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this pacemaker system presented the emergency room (er) with syncope, fainting/loss of consciousness, and a heart rate of 38 beats per minute (bpm).Consult interrogation was unsuccessful, however it was later determined that this pacemaker had entered storage mode.Additionally, the screen displayed a message stating "voltage too low for remaining capacity." the patient was admitted to the hospital, and external pacing was applied due to pacing inhibition.This pacemaker remains in service, however device changeout was anticipated.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 event cause/resolution and product return status.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient implanted with this pacemaker system presented to the emergency room (er) with syncope, fainting/loss of consciousness, and a heart rate of 38 beats per minute (bpm).Consult interrogation was unsuccessful, however it was later determined that this pacemaker had entered storage mode.Additionally, the screen displayed a message stating "voltage too low for remaining capacity." the patient was admitted to the hospital, and external pacing was applied due to pacing inhibition.This pacemaker remains in service, however device changeout was anticipated.No additional adverse patient effects were reported.Product return was requested.Additional information received reported that prior to explant, the patient passed away due to reasons not related to the device.It was noted that the device reverted to storage mode after exceeding the expected longevity.The device is not expected to be returned for analysis.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 21129824
• Report Number: 2124215-2025-00870
• Device Sequence Number: 7676550
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 01/23/2025

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: 11/26/2016
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 405702
• 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: 12/21/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/24/2025
• Date Device Manufactured: 11/26/2014
• 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
• Patient Sex: Male