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

Model Number 4542

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Defective Device (2588); High Capture Threshold (3266)

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

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that this left ventricular lead exhibited high out of range pacing impedance measurements.The lead was tested and measurements were within limits.It was decided to continue monitoring the patient.This lead remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this left ventricular lead exhibited high out of range pacing impedance measurements.The lead was tested and measurements were within limits.It was decided to continue monitoring the patient.This lead remains in service.No further adverse patient effects were reported.Additional information clarified that this lead also exhibited high capture thresholds.

Manufacturer Narrative

Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field d6b: explant date h1: type of reportable event h6: device codes h6: impact codes.Additional information was added to the following fields: b5: describe event or problem field e1: initial reporter last name h6: device codes.

Event Description

It was reported that this left ventricular lead exhibited high out of range pacing impedance measurements.The lead was tested and measurements were within limits.It was decided to continue monitoring the patient.This lead remains in service.No further adverse patient effects were reported.Additional information clarified that this lead also exhibited high capture thresholds.Additional information was received detailing that this lead experienced fracture and exhibited loss of capture, along the high impedance measurements and high pacing thresholds.It was decided to explant and replace this lead.During the procedure it was also noted that the lead experienced insulation damage.Another lead was implanted instead.No further 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 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: 15635699
• MDR Text Key: 303624402
• Report Number: 2124215-2022-42467
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• 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,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2014
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 155776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2012
• 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: 72 YR
• Patient Sex: Female