MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4543

Device Problems Fracture (1260); High impedance (1291); Pocket Stimulation (1463); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)

Event Date 12/23/2019

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 exhibited impedance measurements of greater than 2500 ohms, triggering a lead safety switch.Impedance measurements were normal in unipolar configuration; however, intermittent muscle stimulation was felt by the patient.It was noted that the lead was fractured.The physician would continue monitoring the patient.No adverse patient effects were reported.The lead remains in service.

Manufacturer Narrative

Patient code 3191 is being used to capture the medical intervention of the device reprogramming.

Event Description

Additional information received reported that this left ventricular (lv) lead also exhibited increased threshold measurements.The device was reprogrammed.No adverse patient effects were reported.The lead remains in service.

Event Description

It was reported that this left ventricular (lv) lead exhibited impedance measurements of greater than 2500 ohms, triggering a lead safety switch.Impedance measurements were normal in unipolar configuration; however, intermittent muscle stimulation was felt by the patient.It was noted that the lead was fractured.The physician would continue monitoring the patient.No adverse patient effects were reported.The lead remains in service.Additional information received reported that this left ventricular (lv) lead also exhibited increased threshold measurements.The device was reprogrammed.No adverse patient effects were reported.The lead remains in service.Additional information received reported that this lv lead was later explanted due to high impedances and high thresholds.A new lv lead was implanted.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 9588096
• MDR Text Key: 174956940
• Report Number: 2124215-2020-00482
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2015
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 185776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2013
• 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: 55 YR
• Patient Sex: Male