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

Model Number 4524

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

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that during a routine follow up, it was found that this left ventricular (lv) lead exhibited low out of range pacing impedance measurements, with intermittent jumps.Additionally, it was observed that the lv pacing threshold trend included considerably high measurements, but all other electrical measurements were found to be in range.A damaged lead electrode ring is suspected to be the cause of the reported observations.A patient follow up was scheduled.At this time, no further information is available.The lead remains in service and adverse patient effects have been reported.Additional information was received.The patient has not yet been re-evaluated.No adverse patient effects were reported.The lead remains in service.

Event Description

It was reported that during a routine follow up, it was found that this left ventricular (lv) lead exhibited low out of range pacing impedance measurements, with intermittent jumps.Additionally, it was observed that the lv pacing threshold trend included considerably high measurements, but all other electrical measurements were found to be in range.A damaged lead electrode ring is suspected to be the cause of the reported observations.A patient follow up was scheduled.At this time, no further information is available.The lead remains in service and adverse patient effects have been reported.Additional information was received.The patient has not yet been re-evaluated.No adverse patient effects were reported.The lead remains in service.Additional information was received.The patient underwent surgery, and the implantable device was explanted and replaced.The physician made the decision not to replace this lead, as they did not find evidence of an integrity concern during the procedure.No lead revision was performed at physicians discretion.The lead remains implanted and in-service.

• 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): 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: 18406553
• MDR Text Key: 331504520
• Report Number: 2124215-2023-74097
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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 Expiration Date: 05/13/2006
• Device Model Number: 4524
• Device Catalogue Number: 4524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2004
• 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