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

Model Number 4542

Device Problems Over-Sensing (1438); Connection Problem (2900)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient recently underwent a device upgrade procedure, and a new left ventricular (lv) lead was implanted and placed in the same vessel as the old lv lead, which was left implanted.During the procedure, the old lv lead was accidentally plugged into the atrial port, and the right atrial (ra) lead was capped.The patient was not pacing dependent.Far-field oversensing was seen on the lv lead, which was actually, likely an atrial pace capturing the left ventricle.The patient underwent a revision procedure to correct the issue.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that the patient recently underwent a device upgrade procedure, and a new left ventricular (lv) lead was implanted and placed in the same vessel as the old lv lead, which was left implanted.During the procedure, the old lv lead was accidentally plugged into the atrial port, and the right atrial (ra) lead was capped.The patient was not pacing dependent.Far-field oversensing was seen on the lv lead, which was actually, likely an atrial pace capturing the left ventricle.The patient underwent a revision procedure to correct the issue.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11211842
• MDR Text Key: 228163282
• Report Number: 2124215-2021-01254
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2016
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 303582
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR