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

Model Number 4518

Device Problem High Capture Threshold (3266)

Patient Problem Muscle Stimulation (1412)

Event Date 11/12/2019

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead was surgically capped for a high capture threshold and phrenic nerve stimulation (pns).The lv lead replaced with a non-boston scientific lead.The patient was stable with no additional adverse consequences.

• 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
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9644537
• MDR Text Key: 176881514
• Report Number: 2124215-2019-28816
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: 00802526417672
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 01/29/2020

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: 05/28/2005
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2003
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention