MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; IMPLANTABLE LEAD

Model Number 4524

Device Problems Defective Device (2588); Impedance Problem (2950); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this left ventricular (lv) lead was explanted due to impedance issues that appear to be caused by a lead fracture.This lead was successfully replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead was explanted due to impedance issues that appear to be caused by a lead fracture.This lead was successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: EASYTRAK 3
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9548942
• MDR Text Key: 173648626
• Report Number: 2124215-2019-25566
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526353758
• UDI-Public: 00802526353758
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/25/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2010
• Device Model Number: 4524
• Device Catalogue Number: 4524
• Device Lot Number: 163908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR