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

Model Number 4524

Device Problem Impedance Problem (2950)

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

Event Date 07/06/2023

Event Type  Injury  

Event Description

It was reported that a warning was received regarding the impedance of the the superior vena cava (svc) lead, the right ventricular (rv) defibrillation lead, the left ventricular (lv) lead, the rv bipolar lead, and the rv tip to rv coil lead.A serious injury was noted, and intervention was required due to the aforementioned issues.No additional 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 Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17408904
• MDR Text Key: 319920278
• Report Number: 2124215-2023-39938
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2023

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 Model Number: 4524
• Device Catalogue Number: 4524
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other