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

Model Number 4517

Device Problems Failure to Capture (1081); No Apparent Adverse Event (3189); High Capture Threshold (3266)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that this left ventricular (lv) lead exhibited a non specific device product performance issue.An alert to check the lead was triggered on latitude.The health care professional (hcp) states is a known issue.No further information was provided.This lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

It was reported that this left ventricular (lv) lead exhibited a non-specific device product performance issue.An alert to check the lead was triggered on latitude.The health care professional (hcp) states is a known issue.No further information was provided.This lead remains in service.No adverse patient effects were reported.Additional information was received which indicated the lead was turned off due to high pacing thresholds and loss of capture (loc).This lead was recently tested during a general device change-out procedure and found to be functional.

• Brand Name: EASYTRAK 2
• Type of Device: 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16292758
• MDR Text Key: 308749946
• Report Number: 2124215-2023-04425
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2007
• Device Model Number: 4517
• Device Catalogue Number: 4517
• Device Lot Number: 420698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2005
• 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: 66 YR
• Patient Sex: Male