MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE DEVICE

Model Number	S208
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this system had previously exhibited atrial noise in bipolar configuration.Out of range pacing impedance measurements had triggered the lead safety switch (lss).The caller inquired about the specific measurement that triggered the lss.A boston scientific technical services consultant informed the caller that if the actual value is not available, the lss is triggered when there was an impedance greater than 2500 ohms.There was a small decrease of 100 ohms identified from two months prior.The consultant discussed options for this patient.No adverse patient effects were reported.
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this system had previously exhibited atrial noise in bipolar configuration.Out of range pacing impedance measurements had triggered the lead safety switch (lss).The caller inquired about the specific measurement that triggered the lss.A boston scientific technical services consultant informed the caller that if the actual value is not available, the lss is triggered when there was an impedance greater than 2500 ohms.There was a small decrease of 100 ohms identified from two months prior.The consultant discussed options for this patient.No adverse patient effects were reported.Additional information was received indicating artifact noise and small p-waves were noted on the right atrial channel.The device and leads remain in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.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.
Event or Problem Description
It was reported that this system had previously exhibited atrial noise in bipolar configuration.Out of range pacing impedance measurements had triggered the lead safety switch (lss).The caller inquired about the specific measurement that triggered the lss.A boston scientific technical services consultant informed the caller that if the actual value is not available, the lss is triggered when there was an impedance greater than 2500 ohms.There was a small decrease of 100 ohms identified from two months prior.The consultant discussed options for this patient.No adverse patient effects were reported.Additional information was received indicating artifact noise and small p-waves were noted on the right atrial channel.The device and leads remain in service.No adverse patient effects were reported.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE DEVICE
• 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: 14606125
• Report Number: 2124215-2022-19926
• Device Sequence Number: 19960481
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2024

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: 09/29/2011
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 592742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/26/2023; 03/28/2024
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/10/2023; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2009
• 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 Sex: Female