MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; PACEMAKER

Model Number	S205
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker exhibited noise and oversensing on the ventricular channel.High capture thresholds were noted as well.The involved right ventricular (rv) lead is a non boston scientific product.The patient reported experiencing pocket stimulation.A follow up with cardiology was scheduled.No additional adverse patient effects were reported.At this time, this device system remains in service.

• Brand Name: ALTRUA 20
• 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: 17302155
• Report Number: 2124215-2023-36436
• Device Sequence Number: 17907841
• Product Code: LWP
• UDI-Device Identifier: 00802526499210
• UDI-Public: 00802526499210
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: 04/01/2017
• Device Model Number: S205
• Device Catalogue Number: S205
• Device Lot Number: 569651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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 Sex: Male