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

Model Number	S606
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Codes	Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated.Technical services (ts) was consulted and noted that the device had indicated approximately two years of remaining longevity in 2022.Based on the available information, ts suspected that the device had reached battery capacity depleted (bcd) status.This device remains in service.No adverse patient effects were reported.Additional information was received from the field stating this patient experienced syncope and a device replacement was performed.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker was unable to be interrogated.Technical services (ts) was consulted and noted that the device had indicated approximately two years of remaining longevity in 2022.Based on the available information, ts suspected that the device had reached battery capacity depleted (bcd) status.This device remains in service.No adverse patient effects were reported.Additional information was received from the field stating this patient experienced syncope and a device replacement was performed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correciton applied to f10: patient codes grid.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50376476
• Report Number: 2124215-2026-45193
• Device Sequence Number: 9789871
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: (01)00802526484490(17)130329
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 03/29/2013
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 159980
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 03/31/2011
• 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: 83 YR
• Patient Sex: Female