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

Model Number 4542

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/11/2021

Event Type  Injury  

Event Description

It was reported that this left ventricular exhibited high-out-of-range pacing impedances measuring greater than 2500 ohms.Additionally, the lead did not sense and has loss of capture.It was noted there was no noise that was observed.The patient is scheduled for a revision procedure and they will encourage the lead to be returned for product analysis.At this time, this lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that this left ventricular exhibited high-out-of-range pacing impedances measuring greater than 2500 ohms.Additionally, the lead did not sense and has loss of capture.It was noted there was no noise that was observed.The patient is scheduled for a revision procedure and they will encourage the lead to be returned for product analysis.At this time, this lv lead remains in service.No 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: 11215755
• MDR Text Key: 228237661
• Report Number: 2124215-2021-01154
• 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
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2015
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 157746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR