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

Model Number 4543

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead exhibited variable pace impedance measurements that sometimes rose to high out-of-range pace impedance measurements greater than 2,000 ohms.It was noted that the vectors were previously changed away from the ring as the patient reported feeling stimulation.The field representative was directed to check impedances measurements while the patient was moving.When the patient was leaning forward, impedance measurements went out-of-range.Thresholds were high, however it was noted that the patient had an irregular heart rate and was in atrial fibrillation (af).The field representative was then directed to changing the vector from tip to right ventricular (rv); thresholds were 0.6v@ 1ms, patient did not feel stimulation, and impedance measurements were consistently in the 500 ohm range.Impedances stayed in range when the patient moved to lean forward.This crt-d and lv lead remain in service.No adverse patient effects were reported.

• 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: 11781586
• MDR Text Key: 249222302
• Report Number: 2124215-2021-12700
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2015
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 182504
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2013
• 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 Age: 78 YR