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

Model Number 4517

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

The lead has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this left ventricular (lv) lead was damaged during the extraction of the right ventricular (rv) lead.The lead was explanted.No additional adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead was damaged during the extraction of the right ventricular (rv) lead.The lead was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The lead has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Patient code 3191 captures the reportable event of surgery.This report is being filed to correct the e1: initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter state, initial reporter phone, initial reporter zip/postal code.

• 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
• MDR Report Key: 10234115
• MDR Text Key: 197610995
• Report Number: 2124215-2020-11424
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/11/2010
• Device Model Number: 4517
• Device Catalogue Number: 4517
• Device Lot Number: 434136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR