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

Model Number 4543

Device Problems Failure to Capture (1081); High impedance (1291); Off-Label Use (1494); Under-Sensing (1661); Device Dislodged or Dislocated (2923)

Patient Problem Palpitations (2467)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection revealed the coils were kinked 33.5 cm from the terminal pin.This type of damage is consistent with damage induced during the explant procedure.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the loss of capture, undersensing, high impedances, and dislodgement.

Event Description

It was reported that this pacemaker system exhibited undersensing, loss of capture, and high out of range pacing impedance measurements on the left ventricular (lv) lead, measuring greater than 2000 ohms.It was noted that this lv lead was plugged into the rv port on the pacemaker, which is off-label.The patient experienced palpitations and a chest x-ray was performed.The x-ray indicated the lv lead had dislodged.This lv lead was explanted and replaced.The pacemaker 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): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8021278
• MDR Text Key: 125542653
• Report Number: 2124215-2018-60799
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 802526410994
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2018

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 Expiration Date: 05/15/2019
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 310530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR