MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; IMPLANTABLE LEAD

Model Number 4525

Device Problems Failure to Capture (1081); High impedance (1291); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

Event Type  Injury  

Event Description

It was reported that this lead was surgically abandoned due to impedance issues and loss of capture which initially were attributed to a possible lead fracture.This fracture couldn't being confirmed via visual inspection.Lead damage was attributed to the impedance and loss of capture issues.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8709344
• MDR Text Key: 148344389
• Report Number: 2124215-2019-11912
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526353772
• UDI-Public: 00802526353772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2019

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: 04/21/2006
• Device Model Number: 4525
• Device Catalogue Number: 4525
• Device Lot Number: 154623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR