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

Model Number	S602
Medical Device Problem Codes	Battery Problem (2885); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited a device inefficiency due to low battery.As of this time, this pacemaker remains in service.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: 24639074
• Report Number: 2124215-2026-15182
• Device Sequence Number: 18694036
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: (01)00802526484476(17)131117
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026

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: 11/17/2013
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 779248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/18/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/09/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2011
• 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
• Patient Age: 84 YR
• Patient Sex: Female