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

Model Number 4543

Device Problem High impedance (1291)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

It was reported that the left ventricular (lv) lead pacing impedance (pli) measurement of this cardiac resynchronization therapy pacemaker (crt-p) system was greater than 3000 ohms, which was out-of-range (oor).This triggered a lead safety switch (lss) and a switch to unipolar sensing configuration.Technical services (ts) analyzed presenting electrogram (egm).There was a successful lv automatic threshold test confirming no loss of capture.Further evaluation was recommended.Patient was tested in clinic including isometric testing and the oor impedance could not be reproduced.This device was reprogrammed.It was also noted that this patient experienced muscle stimulation which was resolved with reprogramming.No additional adverse patient effects were reported.Currently, this crt-p system remains in service.

• 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): 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: 16573337
• MDR Text Key: 311683041
• Report Number: 2124215-2023-13002
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2013
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 168480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2011
• 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: 74 YR
• Patient Sex: Male