MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S404
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.The issue was caused by interactions between the device and hospital monitoring or diagnostic equipment when the minute ventilation feature is programmed on.Pacing and sensing functions were tested and the device was verified to operate as expected.
Event or Problem Description
It was reported that the patient with this pacemaker was noted to have a high pacing rate.The patient had previously been put on a life vest after a having experienced a heart attack.The field representative programmed the minute ventilation (mv) sensor off.Boston scientific technical services (ts) discussed that electromagnetic interference from the vest was likely affecting the mv signal and by programming the mv sensor off, the pacing from the device was affected.Ts discussed how equipment such as the vest can affect mv signal.The device remains in service.No adverse patient effects were reported.

• Brand Name: ALTRUA 40
• 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: 14067543
• Report Number: 2124215-2022-03942
• Device Sequence Number: 4766055
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2022

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: 07/07/2011
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 592512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 04/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2009
• 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: 83 YR
• Patient Sex: Female