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

Model Number	K273
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker device was suspected to be draining quicker than expected as device has depleted from 2 years to 5 months battery remaining in a span of 1 month as per current checked.Patient was checked in person and there was no observation of extra battery draining with 89 percent power consumption.Boston scientific technical services (ts) assessed and stated that a correction happened that projecting based on voltage.As of this time, this device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker device was suspected to be draining quicker than expected as device has depleted from 2 years to 5 months battery remaining in a span of 1 month as per current checked.Patient was checked in person and there was no observation of extra battery draining with 89 percent power consumption.Boston scientific technical services (ts) assessed and stated that a correction happened that projecting based on voltage.As of this time, this device remains in service.No adverse patient effects were reported.Additional information was received and indicated that this device was explanted and replaced due to normal battery depletion (nbd).No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker device was suspected to be draining quicker than expected as device has depleted from 2 years to 5 months battery remaining in a span of 1 month as per current checked.Patient was checked in person and there was no observation of extra battery draining with 89 percent power consumption.Boston scientific technical services (ts) assessed and stated that a correction happened that projecting based on voltage.As of this time, this device remains in service.No adverse patient effects were reported.Additional information was received and indicated that this device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental report is being filed to correct the b5: describe event or problem; d4: unique identifier (udi) #; f10: impact codes; and h6: impact codes.

• 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: 21364765
• Report Number: 2124215-2025-07759
• Device Sequence Number: 8519044
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: (01)00802526516962(17)170113(21)405990
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2025
• 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
• Report Date (Section B): 09/03/2025

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: 01/13/2017
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 405990
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 08/22/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/28/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male