MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2; IMPLANTABLE LEAD

Model Number	4518
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise and suspected loss of capture (loc) on the left ventricular (lv) lead channel.The health care professional performed an in-office evaluation and noted changes in morphology during isometrics as well as phrenic nerve stimulation in certain pacing vectors.No adverse patient effects were reported.This system remains in service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise and suspected loss of capture (loc) on the left ventricular (lv) lead channel.The health care professional performed an in-office evaluation and noted changes in morphology during isometrics as well as phrenic nerve stimulation in certain pacing vectors.No adverse patient effects were reported.This system remains in service.Additional information was received indicating that the physician opted to turn the left ventricular (lv) lead pacing off and allow intrinsic activity to occur.No additional adverse patient effects were reported.This system remains in service.

• Brand Name: EASYTRAK 2
• 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: 22093129
• Report Number: 2124215-2025-34564
• Device Sequence Number: 8060027
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: (01)00802526417672(17)111216
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 12/16/2011
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Device Lot Number: 337208
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 12/16/2009
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male