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

Model Number	S606
Medical Device Problem Codes	Pacing Problem (1439); Inaccurate Synchronization (1609)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 was in end of life (eol) and provided inappropriate pacing on a t-wave.As a result, the patient experienced ventricular fibrillation (vf).An external shock was required.No additional adverse patient effects were reported.This device was explanted and replaced due to normal battery depletion.At this time, this device has not been returned to boston scientific for further analysis.
Additional Manufacturer Narrative
This pacemaker was analyzed, passed all tests performed, and exhibited normal device characteristics.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
Event or Problem Description
It was reported that this pacemaker was in end of life (eol) and provided inappropriate pacing on a t-wave.As a result, the patient experienced ventricular fibrillation (vf).An external shock was required.No additional adverse patient effects were reported.This device was explanted and replaced due to normal battery depletion.At this time, this device was already returned to boston scientific for further analysis.

• 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: 21762966
• Report Number: 2124215-2025-20640
• Device Sequence Number: 12951529
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: (01)00802526484490(17)140815
• 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: 2013
• 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,Followup
• Report Date (Section B): 07/25/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/15/2014
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 197260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Male