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

Model Number	K063
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was suspected of premature battery depletion (pbd).Boston scientific technical services (ts) assessed that device was not part on advisory and has been implanted for more than 10 years.Moreover, report showed that the battery at 2.5 years remaining with power consumption.As of this time, this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Correction to field e.Initial reporter.
Event or Problem Description
It was reported that this pacemaker was suspected of premature battery depletion (pbd).Boston scientific technical services (ts) assessed that device was not part on advisory and has been implanted for more than 10 years.Moreover, report showed that the battery at 2.5 years remaining with power consumption.As of this time, this device remains in service.No adverse patient effects were reported.Additional information indicates that this device was explanted due to normal battery depletion.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental report is also being filed to correct the b5.Describe event or problem, e1.Initial reporter last name and e1.Initial reporter email.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 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 this pacemaker was suspected of premature battery depletion (pbd).Boston scientific technical services (ts) assessed that device was not part on advisory and has been implanted for more than 10 years.Moreover, report showed that the battery at 2.5 years remaining with power consumption of 34 watts and 78 percent comparison percentage.As of this time, this device remains in service.No adverse patient effects were reported.Additional information indicates that this device was explanted due to normal battery depletion.No additional adverse patient effects were reported.

• Brand Name: ADVANTIO?
• 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: 20609998
• Report Number: 2124215-2024-69386
• Device Sequence Number: 20669010
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)160707(21)152021
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2025

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: 07/07/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 152021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 04/21/2025; 10/09/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 05/13/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2014
• 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 Age: 89 YR
• Patient Sex: Female