MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO?; PACEMAKER

Model Number	K063
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the battery of this implantable pacemaker was suspected to exhibit premature battery depletion with a longevity drop from 1.5 years to 5 months within a span of 6 months.A request was made to have data from this device analyzed.Data analysis confirmed the device is depleting normally.The battery was outperforming the nominal model.The longevity has exceeded expectations.To date, this device remains in service.No adverse patient effects were reported.Additional information was received and it was reported that this patient with a pacemaker experienced a syncopal episode.The cause of the syncopal event was unable to be determined.It was noted this pacemaker reached elective replacement indicator (eri).Technical services (ts) analyzed the data and noted there were no out of range measurements.This pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.This pacemaker has not been returned for analysis.
Event or Problem Description
It was reported that the battery of this implantable pacemaker was suspected to exhibit premature battery depletion with a longevity drop from 1.5 years to 5 months within a span of 6 months.A request was made to have data from this device analyzed.Data analysis confirmed the device is depleting normally.The battery was outperforming the nominal model.The longevity has exceeded expectations.To date, this device remains in service.No adverse patient effects were reported.Additional information was received and it was reported that this patient with a pacemaker experienced a syncopal episode.The cause of the syncopal event was unable to be determined.It was noted this pacemaker reached elective replacement indicator (eri).Technical services (ts) analyzed the data and noted there were no out of range measurements.This pacemaker was explanted and successfully replaced.No additional adverse patient effects were reported.This pacemaker has not been returned for analysis.
Additional Manufacturer Narrative
The returned ingenio device was analyzed, and it was confirmed 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 devices 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.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of gas gauge/longevity not as expected was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.

• Brand Name: ADVANTIO?
• 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: 24967594
• Report Number: 2124215-2026-22044
• Device Sequence Number: 10455526
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)170212
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 02/12/2017
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 393396
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 02/12/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Female