MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; IMPLANTABLE LEAD

Model Number	4542
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's pacemaker was beeping.Upon interrogation in clinic, it was found that the pacemaker was at its elective replacement indicator (eri).At last check approximately three months prior, the battery life estimate was one year left.An analysis of device data to determine battery status was declined.It was also found that the intrinsic amplitude of the left ventricular (lv) lead was high at greater than 25 mv along with intermittent loss of capture (loc) and high out of range pacing impedance measurements greater than 2500 ohms.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.
Event or Problem Description
It was reported that this patient's pacemaker was beeping.Upon interrogation in clinic, it was found that the pacemaker was at its elective replacement indicator (eri).At last check approximately three months prior, the battery life estimate was one year left.An analysis of device data to determine battery status was declined.It was also found that the intrinsic amplitude of the left ventricular (lv) lead was high at greater than 25 mv along with intermittent loss of capture (loc) and high out of range pacing impedance measurements greater than 2500 ohms.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information, this lv lead was surgically abandoned during a scheduled generator change out procedure.A new lv lead was successfully placed.It was noted that there was a break/fracture in this lead.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Correction: added code for fluoroscopy that was performed prior to revision procedure.
Event or Problem Description
It was reported that this patient's cardiac resynchronization therapy defibrillator (crt-d) was beeping.Upon interrogation in clinic, it was found that the pacemaker was at its elective replacement indicator (eri).At last check approximately three months prior, the battery life estimate was one year left.An analysis of device data to determine battery status was declined.It was also found that the intrinsic amplitude of the left ventricular (lv) lead was high at greater than 25 mv along with intermittent loss of capture (loc) and high out of range pacing impedance measurements greater than 2500 ohms.No additional adverse patient effects were reported.Currently, this system remains in service.According to additional information, this lv lead was surgically abandoned during a scheduled generator change out procedure.A new lv lead was successfully placed.It was noted that there was a suspected break/fracture in this lead after review of fluoroscopy imaging.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 2 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: 21355884
• Report Number: 2124215-2025-07416
• Device Sequence Number: 21070466
• Product Code: NIK
• UDI-Device Identifier: 00802526579806
• UDI-Public: 00802526579806
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2025

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: 04/23/2017
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 307090
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/03/2025; 03/03/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/04/2025; 03/05/2025
• Date Device Manufactured: 04/23/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female