MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	4548
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited increasing threshold measurements.During a routine device replacement procedure this lv was connected to the new replacement device, but significant muscle stimulation was observed.Attempts to program around the muscle stimulation were unsuccessful.The lv lead was surgically capped/abandoned (i.E., it remains implanted, but is no longer in service).
Additional Manufacturer Narrative
This product remains implanted and has not been returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: EASYTRAK 3 IS-1
• 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: 16751878
• Report Number: 2124215-2023-17922
• Device Sequence Number: 18274720
• Product Code: LWP
• UDI-Device Identifier: 00802526420276
• UDI-Public: 00802526420276
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: P010012/S032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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: 07/31/2015
• Device Model Number: 4548
• Device Catalogue Number: 4548
• Device Lot Number: 172245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown