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 Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Heart Failure (2206)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported this left ventricular (lv) lead was part of a system revision due to infection.This lv lead was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

No additional information is available.If additional information becomes available, this report will be updated at that time.

Event Description

Additional information was received that this patient is pacemaker dependent, so temporary pacing was used following the system revision, but the patient had low blood pressure and showed exacerbation of heart failure.The patient was admitted to the intensive care unit.The physician suspected the tricuspid valve was damaged during the system explant procedure.Further information was provided that the temporary pacing system was a competitor product.It was also noted a competitor's left ventricular (lv) lead was implanted to help with the patient's heart failure.No additional adverse patient effects were reported.Lead return is not expected.

• 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): 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: 8421747
• MDR Text Key: 138825912
• Report Number: 2124215-2019-00322
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2013
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 147599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• 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: 73 YR