MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; IMPLANTABLE LEAD

Model Number 4543

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problem Dizziness (2194)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) system was evaluated in the emergency department.Pauses were observed on the monitor and the patient experienced lightheadedness during them.The health care professional (hcp) was not able to provide the length of these pauses to boston scientific technical services (ts).The hcp stated that an external pacemaker was placed on this patient.This left ventricular (lv) lead exhibited noise which was suspected to be the result of electromagnetic interference (emi) due to the external pacemaker placed on the patient.Ts confirmed the noise was not detected by the device.However, loss of capture (loc) on this lv lead was suspected.Ts advised the hcp to contact a field representative for further evaluation.No additional adverse patient effects were reported.At this time, this device system remains in service.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: IMPLANTABLE LEAD
• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17506296
• MDR Text Key: 320889906
• Report Number: 2124215-2023-42900
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2023

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: 10/15/2011
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 151892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2009
• 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): Required Intervention; Hospitalization
• Patient Age: 99 YR
• Patient Sex: Male