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

Model Number	S606
Medical Device Problem Codes	Premature Discharge of Battery (1057); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an in-office visit there was difficulty interrogating this pacemaker.Magnet response was found, but there was concerns of premature battery depletion.Subsequently, a revision procedure was performed and the pacemaker was explanted and replaced.No additional 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: 23618849
• Report Number: 2124215-2025-85515
• Device Sequence Number: 18653265
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: (01)00802526484490(17)150426
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: 04/26/2015
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 203069
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 05/02/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female