MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S602
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this pacemaker system, implanted with non boston scientific leads, was admitted to the hospital and telemetry revealed 6-8 second pauses in pacing.The pacemaker was programmed to a fixed output of 2.5v, and threshold measurement was 0.6v.Sensitivity was programmed to 2.5mv.Impedance measurements were stable at around 550 ohms, and there were no stored events.Electrolyte levels were not checked, and the patient had an unspecified medical condition unrelated to the device.It was noted that the non boston scientific right atrial (ra) lead was known to be fractured a centimeter from the tip of the lead, however the onset was not known.There was no lead safety switch (lss) noted and the device was sensing in bipolar.Technical services (ts) discussed troubleshooting/programming options and possible causes, including possible oversensing.This pacemaker system remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: ALTRUA 60
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 21063362
• Report Number: 2124215-2025-00110
• Device Sequence Number: 18221791
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: 00802526484476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 05/25/2013
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 774554
• 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: 12/10/2024
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 05/27/2011
• 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
• Patient Age: 88 YR
• Patient Sex: Male