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

Model Number 4543

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 08/30/2018

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead is was presenting high impedance out of range indicative of a lead fracture.Device remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead is was presenting high impedance out of range indicative of a lead fracture.Device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Amendment corrected fields: b5 describe event or problem h6 impact codes and device codes pleasae disregards previous reports #2124215-2022-31221, this event is no longer reportable since it is part of report.

Manufacturer Narrative

Amendment corrected fields: b5 describe event or problem h6 impact codes and device codes.Pleasae disregards mdr # 15514555, this event is no longer reportable since it is part of a vintage complaint (b)(4).

Event Description

It was reported that this left ventricular (lv) lead is was presenting high impedance out of range indicative of a lead fracture.Device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Amendment corrected fields: b5 describe event or problem h6 impact codes and device codes please disregards previous reports #2124215-2022-31221, this complaint is a duplicate and has already been reported under report #2124215-2012-03918.

Event Description

It was reported that this left ventricular (lv) lead is was presenting high impedance out of range indicative of a lead fracture.Device remains in service.No additional 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: 15246310
• MDR Text Key: 298107819
• Report Number: 2124215-2022-31221
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2012
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 158549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2010
• 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: 70 YR
• Patient Sex: Male