MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4542

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that this left ventricular (lv) lead was not successfully implanted after it dissected the posterior lateral vein.Since there were no other veins available to place the lead, the lead was removed and the patient received an epicardial lead.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Resistance and pressure tests were completed to assess lead electrical performance and insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: EASYTRAK 2 IS-1
• 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 PR ; EI
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7984121
• MDR Text Key: 124306420
• Report Number: 2124215-2018-17131
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: Health Professional
• Device Expiration Date: 09/12/2019
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 310131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• 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
• Treatment: 0185; 4047; 4542; 7741; G051
• Patient Outcome(s): Life Threatening; Required Intervention