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

Model Number 4518

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

It was reported that this left ventricular lead exhibited high out of range pacing impedance measurements and failure to capture.No changes have been performed.This lead remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this left ventricular lead exhibited high out of range pacing impedance measurements and failure to capture.No changes have been performed.This lead remains in service.No further adverse patient effects were reported.Additional information was received detailing the concerns regarding a possible lead fracture.Further evaluation of the lead was discussed.

• Brand Name: EASYTRAK 2
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16732712
• MDR Text Key: 313219818
• Report Number: 2124215-2023-17397
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: 00802526417672
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/22/2006
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Sex: Male