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

Model Number 4543

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); High Capture Threshold (3266)

Patient Problem No Code Available (3191)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead exhibited loss of capture (loc) at 7.5v @ 2.0ms and high out-of-range pace impedance measurements greater than 3,000 ohms.It was determine via fluoroscopy that this lead was fractured.This lead was surgically abandoned, and a new lead was successfully implanted.No additional adverse patient effects were reported.

• 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; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11227738
• MDR Text Key: 241236539
• Report Number: 2124215-2020-29045
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

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: 06/15/2013
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 166968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2011
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR