MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA? 60; PACEMAKER

Model Number	S606
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker system exhibited high out of range impedance measurements for its right atrial (ra) lead during its scheduled explant procedure.Technical services (ts) was consulted and discussed troubleshooting options to test the ra lead and ensure its integrity.This pacemaker was explanted and replaced as scheduled.This device has been received for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.The product has been received for analysis.This report will be updated upon completion of analysis.A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.The product has been received for analysis.This report will be updated upon completion of analysis.A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this pacemaker system exhibited high out of range impedance measurements for its right atrial (ra) lead during its scheduled explant procedure.Technical services (ts) was consulted and discussed troubleshooting options to test the ra lead and ensure its integrity.This pacemaker was explanted and replaced as scheduled.This device has been received for analysis.No adverse patient effects were reported.Additional information from the field indicates the ra lead was programmed to its unipolar pacing vector, with the measurements within range for this setting.No adverse patient effects were reported.

• Brand Name: ALTRUA? 60
• 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: 25243986
• Report Number: 2124215-2026-27452
• Device Sequence Number: 16088950
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: (01)00802526484490(17)130121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 01/21/2013
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 154664
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 01/25/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female