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

Model Number	K062
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
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 patient implanted with this pacemaker system presented to the emergency room (er) after a syncopal episode.Review of the presenting electrogram (egm) suggested the pacemaker was operating as programmed, however the health care professional (hcp) states loss of capture (loc) was observed on the monitor with no associated symptoms reported.Additionally, two non-sustained ventricular tachycardia (nsvt) were stored and appeared to contain noise but had occurred after the time of the syncopal episode.The most recent auto threshold test was 1.2v @ 0.4 ms.Further device/lead testing was advised.This pacemaker system remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the patient implanted with this pacemaker system presented to the emergency room (er) after a syncopal episode.Review of the presenting electrogram (egm) suggested the pacemaker was operating as programmed, however the health care professional (hcp) states loss of capture (loc) was observed on the monitor with no associated symptoms reported.Additionally, two non-sustained ventricular tachycardia (nsvt) were stored and appeared to contain noise, but had occurred after the time of the syncopal episode.The most recent auto threshold test was 1.2v @ 0.4 ms.Further device/lead testing was advised.This pacemaker system remains in service.No adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced, and the non-boston scientific right ventricular (rv) lead was surgically abandoned and replaced during the same procedure.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing/sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient implanted with this pacemaker system presented to the emergency room (er) after a syncopal episode.Review of the presenting electrogram (egm) suggested the pacemaker was operating as programmed, however the health care professional (hcp) states loss of capture (loc) was observed on the monitor with no associated symptoms reported.Additionally, two non-sustained ventricular tachycardia (nsvt) were stored and appeared to contain noise, but had occurred after the time of the syncopal episode.The most recent auto threshold test was 1.2v @ 0.4 ms.Further device/lead testing was advised.This pacemaker system remains in service.No adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced, and the non boston scientific right ventricular (rv) lead was surgically abandoned and replaced during the same procedure.No additional 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: 21393574
• Report Number: 2124215-2025-08917
• Device Sequence Number: 15584982
• Product Code: LWP
• UDI-Device Identifier: 00802526516658
• UDI-Public: (01)00802526516658(17)160306(21)120564
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2025

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: 03/06/2016
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 120564
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 05/30/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/21/2025; 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male