MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4518

Device Problems Failure to Capture (1081); Fracture (1260); Pocket Stimulation (1463); Impedance Problem (2950)

Patient Problems Muscle Stimulation (1412); No Code Available (3191)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this left ventricular (lv) lead had a fracture resulting to no capture, muscle stimulation, and high impedance measurements.There is no known intervention information as of the moment.The lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.The available information suggests this lead is not available for return.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided or upon completion of analysis if the lead is returned at a later date.

Event Description

Additional information was received indicating this lead was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.Two segments of the lead were returned; a terminal segment approximately 11 centimeters (cm) in length and a middle segment approximately 12 centimeters (cm) in length.The middle segment returned was only lead insulation.Resistance tests were completed on the terminal segment to assess lead electrical performance.Measurements throughout these tests were within normal limits.Laboratory analysis on the returned segments did not identify any characteristics that would have caused or contributed to the reported clinical observations.

Event Description

Portions of the lead were returned for analysis.

• Brand Name: EASYTRAK 2
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9924011
• MDR Text Key: 186741872
• Report Number: 2124215-2020-02330
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526417672
• UDI-Public: 00802526417672
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2008
• Device Model Number: 4518
• Device Catalogue Number: 4518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR