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

Model Number	K273
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that technical services (ts) was contacted to discuss programming options for the patients minute ventilation (mv) and accelerometer rate response.The patient's heartrate was sometimes increasing too quickly and sometimes not at all.Ts discussed the rate response settings and made programming recommendations.The device and leads remain in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Investigation determined that the minute ventilation (mv) sensor in ingenio devices has the potential to increase the pacing rate to the maximum sensor rate more quickly than expected.As a result, a software update was released in 2013 that reduced the minimum mv response factor settings and re-distributed the remaining mv response factors to provide a consistent change in sensor rate across the range of mv response factors.This corrective action is expected to reduce, but not eliminate the occurrence of this behavior.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Investigation determined that the minute ventilation (mv) sensor in ingenio devices has the potential to increase the pacing rate to the maximum sensor rate more quickly than expected.As a result, a software update was released in 2013 that reduced the minimum mv response factor settings and re-distributed the remaining mv response factors to provide a consistent change in sensor rate across the range of mv response factors.This corrective action is expected to reduce, but not eliminate the occurrence of this behavior.
Event or Problem Description
It was reported that technical services (ts) was contacted to discuss programming options for the patients minute ventilation (mv) and accelerometer rate response.The patient's heartrate was sometimes increasing too quickly and sometimes not at all.Ts discussed the rate response settings and made programming recommendations.The device and leads remain in service.No adverse patient effects were reported.

• Brand Name: VITALIO
• Common Device Name: IMPLANTABLE DEVICE
• 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: 15534181
• Report Number: 2124215-2022-39337
• Device Sequence Number: 7838503
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/29/2017
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 406195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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
• Patient Age: 40 YR
• Patient Sex: Male