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

Model Number 4542

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that left ventricular (lv) lead was surgically abandoned.The reason was not provided.This lead was successfully replaced.No additional adverse patient effects were reported.The local area field representative was contacted for additional information, however at this time no further information is available.

• 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: 11215946
• MDR Text Key: 228242547
• Report Number: 2124215-2021-01391
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2011
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 132287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR