MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; PACEMAKER

Model Number	K273
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Battery Problem (2885)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the projected longevity for this pacemaker decreased from one and half years to less than three months in a six-month period.Technical services (ts) was consulted and discussed that the minute ventilation (mv) had been turned off and was now turned back on along with signal artifact monitoring (sam).An analysis of device data noted that the change in longevity was unrelated to mv and sam and noted there is no evidence of premature battery depletion (pbd), however the battery is behaving far from predictions.Ts recommended a device replacement.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the projected longevity for this pacemaker decreased from one and half years to less than three months in a six-month period.Technical services (ts) was consulted and discussed that the minute ventilation (mv) had been turned off and was now turned back on along with signal artifact monitoring (sam).An analysis of device data noted that the change in longevity was unrelated to mv and sam and noted there is no evidence of premature battery depletion (pbd), however the battery is behaving far from predictions.Ts recommended a device replacement.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the projected longevity for this pacemaker decreased from one and half years to less than three months in a six month period.Technical services (ts) was consulted and discussed that the minute ventilation (mv) had been turned off and was now turned back on along with signal artifact monitoring (sam).An analysis of device data noted that the change in longevity was unrelated to mv and sam and noted there is no evidence of premature battery depletion (pbd), however the battery is behaving far from predictions.Ts recommended a device replacement.This device remains in service.No adverse patient effects were reported.Additional information was received, the patient with this pacemaker experienced symptoms and there were questions if the device lost rate response due to elective replacement indicator (eri).Technical services (ts) discussed rate response continues when explant indicator is reached.This device remains in service.No adverse patient effects were reported.

• 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: 20118232
• Report Number: 2124215-2024-54656
• Device Sequence Number: 20638375
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 09/10/2016
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 102183
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 11/13/2024
• Date Device Manufactured: 09/13/2014
• 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
• Patient Sex: Female