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

Model Number	S601
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438); High Capture Threshold (3266); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was oversensing on the right ventricular (rv) lead channel of this pacemaker system.Technical services (ts) reviewed electrogram (egm) and noted that there was difficulty with obtaining correct telemetry because it was difficult to read the pacing and sensing markers as well as oversensing.After troubleshooting in clinic, it was found that the threshold had gone up and there was intermittent capture of the rv lead.The output was increased by reprogramming and resolution was obtained.This patient had intrinsic sensed beat coming through.No adverse patient effects were reported.Currently, this pacemaker system remains in service.
Event or Problem Description
It was reported that there was oversensing on the right ventricular (rv) lead channel of this pacemaker system.Technical services (ts) reviewed electrogram (egm) and noted that there was difficulty with obtaining correct telemetry because it was difficult to read the pacing and sensing markers as well as oversensing.After troubleshooting in clinic, it was found that the threshold had gone up and there was intermittent capture of the rv lead.The output was increased by reprogramming and resolution was obtained.This patient had intrinsic sensed beat coming through.No adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information, this device was explanted electively for normal battery depletion (nbd).Another pacemaker was successfully placed.No adverse patient effects were reported outside of scheduled replacement procedure.

• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17004138
• Report Number: 2124215-2023-26343
• Device Sequence Number: 7151188
• Product Code: LWP
• UDI-Device Identifier: 00802526484469
• UDI-Public: 00802526484469
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 02/16/2014
• Device Model Number: S601
• Device Catalogue Number: S601
• Device Lot Number: 171466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2012
• 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
• Patient Age: 82 YR
• Patient Sex: Male