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

Model Number	S601
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Defective Device (2588)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that doing a pacemaker change out, a polarity change was observed with no known reason.This caused possible noise oversensing and finally five seconds of asystole were experienced by the patient until the lead was connected to the pacing system analyzer.It was confirmed that the patient is fine after the procedure.The new device was successfully implanted and the explanted device is expected to be returned for analysis.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 60
• Common Device Name: IMPLANTABLE 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: 13675709
• Report Number: 2124215-2022-05078
• Device Sequence Number: 5275413
• Product Code: LWP
• UDI-Device Identifier: 00802526484469
• UDI-Public: 00802526484469
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 05/25/2012
• Device Model Number: S601
• Device Catalogue Number: S601
• Device Lot Number: 143731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2010
• 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: 67 YR
• Patient Sex: Male