MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; IMPLANTABLE LEAD

Model Number 4524

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported that there were difficulties getting this left ventricular (lv) lead into the header of the cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) provided a resolution option.No adverse patient effects were reported.

Event Description

It was reported that there were difficulties getting this left ventricular (lv) lead into the header of the cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) provided a resolution option.No adverse patient effects were reported.Additional information indicates that this lead able to be connected to the header of the device after pushing the lead in harder.No adverse patient effects were reported.

• Brand Name: EASYTRAK 3
• 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: 17859780
• MDR Text Key: 324777794
• Report Number: 2124215-2023-54247
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526353758
• UDI-Public: 00802526353758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2008
• Device Model Number: 4524
• Device Catalogue Number: 4524
• Device Lot Number: 160195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2006
• 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 Age: 86 YR
• Patient Sex: Male