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

Model Number 4542

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Material Integrity Problem (2978); High Capture Threshold (3266)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

It was reported that this left ventricular (lv) lead exhibited high capture thresholds, failure to capture, noise, oversensing, pacing inhibition and pacing impedance high due to lead fracture.The patient also experienced pain due to this issue.Additional information indicates that during removal of this lead, the distal end of the lead separated, leaving the end of the lead in the left ventricle coronary sinus branch.The left ventricular (lv) lead ring electrode separated from the broken end of the lead, traveled up through the pulmonary artery and is believed to be stuck against the pulmonic valve.A team of surgical physicians decided not to retrieve the electrode at this time due to the risk being higher than the benefit for the patient.This lead was successfully replaced.No additional adverse patient effects were reported.The complaint device was not returned by the customer; therefore, no product analysis could be performed.

• 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; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10730764
• MDR Text Key: 212872229
• Report Number: 2124215-2020-21635
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

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: 04/23/2011
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 132540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR