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

Model Number	S606
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a lead safety switch (lss) was activated in right ventricular (rv) lead of this pacemaker system, switching from bipolar to unipolar mode due to an unspecified out of range impedance measurement.Technical services (ts) explained details about the lss and recommended further rv lead evaluation.Ts also provided programming options.The rv lead is a non-boston scientific device.No adverse patient effects were reported.This pacemaker remains in service.

• 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: 21652596
• Report Number: 2124215-2025-17261
• Device Sequence Number: 7424583
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: 00802526484490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 04/08/2013
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 161013
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/20/2025
• Date Device Manufactured: 04/13/2011
• 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: 86 YR
• Patient Sex: Female