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

Model Number	K063
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Asystole (4442)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this pacemaker system visited the hospital after a syncopal episode.The health care professional (hcp) interrogated the device noting that it had reached end of life (eol) status and the patient to be in asystole.The hcp made a consult call to technical services (ts) and requested further review of the device stored data.Further review of the presenting electrogram (egm) showed a lead safety switch (lss) was triggered which changed right ventricular (rv) lead settings from bipolar to unipolar configurations due to high out of range rv lead pacing impedances recorded to have been greater than 2000 ohms.It was noted that the rv lead is a non-boston scientific product.The hcp suspected possible cause to be a spring contact issue.Ts discussed reprogramming options with the hcp and referred them to the local field representative.The hcp noted that the physician has scheduled a device replacement procedure due to device reaching eol status.At this time, the pacemaker and rv lead remain in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that the patient with this pacemaker system visited the hospital after a syncopal episode.The health care professional (hcp) interrogated the device noting that it had reached end of life (eol) status and the patient to be in asystole.The hcp made a consult call to technical services (ts) and requested further review of the device stored data.Further review of the presenting electrogram (egm) showed a lead safety switch (lss) was triggered which changed right ventricular (rv) lead settings from bipolar to unipolar configurations due to high out of range rv lead pacing impedances recorded to have been greater than 2000 ohms.It was noted that the rv lead is a non-boston scientific product.The hcp suspected possible cause to be a spring contact issue.Ts discussed reprogramming options with the hcp and referred them to the local field representative.The hcp noted that the physician has scheduled a device replacement procedure due to device reaching eol status.At this time, the pacemaker and rv lead remain in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that the patient with this pacemaker system visited the hospital after a syncopal episode.The health care professional (hcp) interrogated the device noting that it had reached end of life (eol) status and the patient to be in asystole.The hcp made a consult call to technical services (ts) and requested further review of the device stored data.Further review of the presenting electrogram (egm) showed a lead safety switch (lss) was triggered which changed right ventricular (rv) lead settings from bipolar to unipolar configurations due to high out of range rv lead pacing impedances recorded to have been greater than 2000 ohms.It was noted that the rv lead is a non-boston scientific product.The hcp suspected possible cause to be a spring contact issue.Ts discussed reprogramming options with the hcp and referred them to the local field representative.The hcp noted that the physician has scheduled a device replacement procedure due to device reaching eol status.At this time, the pacemaker and rv lead remain in service.No additional adverse patient effects were reported.Subsequently additional information was received that reported that this pacemaker was explanted due to normal battery depletion (nbd) and replaced with a new device successfully.The physician opted to revise and reuse the non-boston scientific rv lead.No additional adverse patient effects were reported.

• 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: 21688021
• Report Number: 2124215-2025-18275
• Device Sequence Number: 8774046
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: (01)00802526516702(17)160214
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2025

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: 02/14/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 145890
• 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: 03/01/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 04/29/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/16/2025; 05/05/2025
• Date Device Manufactured: 02/18/2014
• 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; Other
• Patient Age: 89 YR
• Patient Sex: Female