MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; PACEMAKER

Model Number	S401
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker displayed an error message and device replacement was recommended.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
With the available information, boston scientific cannot confirm the clinical observations due to lack of product return.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.This device remains in-service.As such, physical analysis has not been conducted in our laboratory.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If additional information is provided in the future and/or the device is returned for analysis, a supplemental report will be issued.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.
Event or Problem Description
It was reported that this pacemaker displayed an error message and device replacement was recommended.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 40
• 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: 24135317
• Report Number: 2124215-2026-03899
• Device Sequence Number: 10387302
• Product Code: LWP
• UDI-Device Identifier: 00802526484438
• UDI-Public: (01)00802526484438(17)140215
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 03/04/2026

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: 02/15/2014
• Device Model Number: S401
• Device Catalogue Number: S401
• Device Lot Number: 574844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 02/17/2012
• 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: 67 YR
• Patient Sex: Male