MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA? 20; PACEMAKER

Model Number	S208
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated as it was getting an error message on two communicators.The device experienced safety switch.The device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated as it was getting an error message on two communicators.The device experienced safety switch.The device remains in service.No adverse patient effects were reported.Additional information received, the physician plans to perform an explant once the device reaches elective replacement indicator (eri).
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.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.A risk review was completed and confirmed that the event of pacing impedance high out of range was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated as it was getting an error message on two communicators.The device experienced safety switch.The device remains in service.No adverse patient effects were reported.Additional information received, the physician plans to perform an explant once the device reaches elective replacement indicator (eri).

• Brand Name: ALTRUA? 20
• 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: 23712448
• Report Number: 2124215-2025-88943
• Device Sequence Number: 13332872
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: (01)00802526484421(17)140209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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: 02/09/2014
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 598996
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 03/18/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/09/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2012
• 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
• Patient Age: 82 YR
• Patient Sex: Female