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

Model Number	K273
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery longevity of this implantable pacemaker indicated 2 years remaining a year ago, and recently showed less than 3 months remaining.Boston scientific technical service (ts) reviewed with healthcare professional (hcp) and discussed that there were no changes in output and threshold and with atrial fibrillation (af) burden at less than 1 percent.Ts also confirmed with hcp that this device has low consumption values.Furthermore, ts explained this it could be voltage was higher that the hardware based projected longevity or was overachieving and advised engineering analysis.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the battery longevity of this implantable pacemaker indicated 2 years remaining a year ago, and recently showed less than 3 months remaining.Boston scientific technical service (ts) reviewed with healthcare professional (hcp) and discussed that there were no changes in output and threshold and with atrial fibrillation (af) burden at less than 1 percent.Ts also confirmed with hcp that this device has low consumption values.Furthermore, ts explained this it could be voltage was higher that the hardware based projected longevity or was overachieving and advised engineering analysis.This device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the battery longevity of this implantable pacemaker indicated 2 years remaining a year ago, and recently showed less than 3 months remaining.Boston scientific technical service (ts) reviewed with healthcare professional (hcp) and discussed that there were no changes in output and threshold and with atrial fibrillation (af) burden at less than 1 percent.Ts also confirmed with hcp that this device has low consumption values.Furthermore, ts explained this it could be voltage was higher that the hardware based projected longevity or was overachieving and advised engineering analysis.This device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned ingenio device was analyzed, and it was confirmed that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.A cross-functional investigation determined that the unexpected change in observed longevity is due to a mismatch between the actual battery voltage and the expected battery voltage per the nominal battery discharge model (which represents how the device's battery voltage typically decreases over time).Correction to field h11: additional mfr narrative.The returned ingenio device was analyzed, and it was confirmed that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.It was determined that the unexpected change in observed longevity is due to a mismatch between the actual battery voltage and the expected battery voltage per the nominal battery discharge model (which represents how the device's battery voltage typically decreases over time).In some devices, the actual battery voltage remains higher than the nominal model earlier in device life (which results in a higher-than-expected remaining longevity) and then becomes lower than the nominal model later in device life (which results in the remaining longevity appearing to decrease more quickly than expected between routine follow-ups).Boston scientific devices will automatically adjust remaining longevity estimates to maintain the 90-day therapy window between explant and battery capacity depleted.In this case, the battery did not deplete prematurely, rather, the replacement indicator (and associated remaining longevity) was adjusted later in device life to ensure a 90-day replacement period.
Event or Problem Description
It was reported that the battery longevity of this implantable pacemaker indicated 2 years remaining a year ago, and recently showed less than 3 months remaining.Boston scientific technical service (ts) reviewed with healthcare professional (hcp) and discussed that there were no changes in output and threshold and with atrial fibrillation (af) burden at less than 1 percent.Ts also confirmed with hcp that this device has low consumption values.Furthermore, ts explained this it could be voltage was higher that the hardware based projected longevity or was overachieving and advised engineering analysis.This device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned ingenio device was analyzed, and it was confirmed that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.A cross-functional investigation determined that the unexpected change in observed longevity is due to a mismatch between the actual battery voltage and the expected battery voltage per the nominal battery discharge model (which represents how the device's battery voltage typically decreases over time).

• Brand Name: VITALIO
• Common Device Name: IMPLANTABLE 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: 20088194
• Report Number: 2124215-2024-53872
• Device Sequence Number: 12678646
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: (01)00802526516962(17)161121(21)405651
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2025

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: 11/21/2016
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 405651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 06/30/2025; 07/28/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/04/2024; 07/25/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2014
• 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: Required Intervention; Hospitalization
• Patient Sex: Male