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

Model Number 4542

Device Problems Low impedance (2285); High Capture Threshold (3266)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

It was reported that, this right ventricular (rv) lead exhibited a significant decrease on the pacing impedance.No out of range measurements were noted.Additionally, the rv lead exhibited high pacing thresholds.This rv remains in service.No adverse patient effects were reported.

• 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; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17700307
• MDR Text Key: 322860381
• Report Number: 2124215-2023-48735
• Device Sequence Number: 1
• Product Code: NIK
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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