MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTIO; PACEMAKER

Model Number	K063
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular (rv) channel.Technical services (ts) was consulted and recommended programming and troubleshooting options.It was noted that this patient is pacemaker dependent, but did not experience greater than two seconds of asystole.Further information was received that this device was explanted.No additional adverse patient effects were reported.This device has been received for analysis.
Event or Problem Description
It was reported that this pacemaker exhibited noise, oversensing and pacing inhibition on the right ventricular (rv) channel.Technical services (ts) was consulted and recommended programming and troubleshooting options.It was noted that this patient is pacemaker dependent, but did not experience greater than two seconds of asystole.Further information was received that this device was explanted.No additional adverse patient effects were reported.This device has been received for 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, and 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.

• 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: 19489006
• Report Number: 2124215-2024-34925
• Device Sequence Number: 7106468
• Product Code: LWP
• UDI-Device Identifier: 00802526516702
• UDI-Public: 00802526516702
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 09/26/2024

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: 11/27/2016
• Device Model Number: K063
• Device Catalogue Number: K063
• Device Lot Number: 391765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2014
• 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: 73 YR
• Patient Sex: Male