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

Model Number 4543

Device Problems Pocket Stimulation (1463); Impedance Problem (2950)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this left ventricular (lv) lead caused the patient to experience diaphragmatic stimulation.The lead was surgically abandoned.No additional adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead caused the patient to experience diaphragmatic stimulation.Additional information received indicates that this lv lead also exhibited high impedance.The lead was surgically abandoned.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• 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
• MDR Report Key: 11767448
• MDR Text Key: 248767915
• Report Number: 2124215-2021-11953
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): Y
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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: 09/04/2006
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 102370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR