MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE LEAD

Model Number	4549
Medical Device Problem Code	Extracardiac stimulation (1463)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product was manufactured before the implementation of the udi regulation, so the complete udi is unavailable.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead a diaphragmatic stimulation by the abdomen and thumping in on the chest and reprogramming was made and resolved.However, the symptoms reoccurred.Patient was suggested to have this lv lead turned off.As of this time, this lv remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was created to capture the additional information received which indicates that the left ventricular (lv) lead was not programmed off and still active as of the present time.This observation no longer meets the definition of malfunction as it was confirmed that the lead was operating normally.Amending mdr decision to mdr=no report.This product was manufactured before the implementation of the udi regulation, so the complete udi is unavailable.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead a diaphragmatic stimulation by the abdomen and thumping in on the chest and reprogramming was made and resolved.However, the symptoms reoccurred.Patient was suggested to have this lv lead turned off.As of this time, this lv remains in service.No additional adverse patient effects were reported.Additional information received which indicates that lv lead is still on and active with no stimulation as of the present time.No adverse patient effects were reported.

• Brand Name: EASYTRAK 3 IS-1
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23666175
• Report Number: 2124215-2025-87277
• Device Sequence Number: 10298590
• Product Code: LWP
• UDI-Device Identifier: 00802526420399
• UDI-Public: (01)00802526420399(17)150801
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 08/01/2015
• Device Model Number: 4549
• Device Catalogue Number: 4549
• Device Lot Number: 184821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 08/01/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female