MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO?; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	K063
Medical Device Problem Codes	Premature Discharge of Battery (1057); Data Problem (3196); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional pertinent information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker exhibited a failure during interrogation in which data could not be read.Additionally, the patient stated that their battery was dead.Technical services (ts) recommended follow-up with a local boston scientific representative.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited a failure during interrogation in which data could not be read.Additionally, the patient stated that their battery was dead.Technical services (ts) recommended follow-up with a local boston scientific representative.This device remains in service.No adverse patient effects were reported.Additional information was received that this device reached end of life as of 25 october 2025 as a result of normal battery depletion.The patient will be scheduled for a future device replacement.At this time this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If additional pertinent information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker exhibited a failure during interrogation in which data could not be read.Additionally, the patient stated that their battery was dead.Technical services (ts) recommended follow-up with a local boston scientific representative.This device remains in service.No adverse patient effects were reported.Additional information was received that this device reached end of life as of (b)(6) 2025 as a result of normal battery depletion.The patient will be scheduled for a future device replacement.At this time this device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Correction: h6 device codes if additional pertinent information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.A risk review was completed and confirmed that the event of difficult to interrogate/telemetry (wand) 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 to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Correction: h6 device codes if additional pertinent information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker exhibited a failure during interrogation in which data could not be read.Additionally, the patient stated that their battery was dead.Technical services (ts) recommended follow-up with a local boston scientific representative.This device remains in service.No adverse patient effects were reported.Additional information was received that this device reached end of life as of 25 october 2025 as a result of normal battery depletion.The patient will be scheduled for a future device replacement.At this time this device remains in service.No adverse patient effects were reported.

• Brand Name: ADVANTIO?
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 24082284
• Report Number: 2124215-2026-02807
• Device Sequence Number: 5878593
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)161021
• 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: 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,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 10/21/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 390358
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 03/23/2026; 04/22/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/16/2026; 03/23/2026; 04/23/2026
• Date Device Manufactured: 10/21/2014
• 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
• Patient Age: 83 YR
• Patient Sex: Female