MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	4542
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a routine generator replacement, it was observed that the insulation of the implantable lead had sustained damage due to an acute bend in the lead.Despite this finding, all lead functions were stable.The physician opted to retain the existing lead and will monitor for any future complications.The patient is scheduled for regular follow-up appointments.The lead remains in service, and no adverse patient effects have been reported.
Additional Manufacturer Narrative
The lead remains in service; therefore, a technical analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of {insert name of primary code} was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that during a routine generator replacement, it was observed that the insulation of the implantable lead had sustained damage due to an acute bend in the lead.Despite this finding, all lead functions were stable.The physician opted to retain the existing lead and will monitor for any future complications.The patient is scheduled for regular follow-up appointments.The lead remains in service, and no adverse patient effects have been reported.

• Brand Name: EASYTRAK 2 IS-1
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 24311529
• Report Number: 2124215-2026-07610
• Device Sequence Number: 4837587
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: (01)00802526410901(17)151008
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 10/08/2015
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 160858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 10/08/2013
• 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
• Patient Age: 79 YR
• Patient Sex: Female