MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 2; IMPLANTABLE LEAD

Model Number 4518

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Unspecified Infection (1930); Respiratory Failure (2484)

Event Date 07/09/2015

Event Type  Death  

Event Description

Boston scientific received information that this patient was presented back to the electrophysiology (ep) laboratory on (b)(6), 2015.The system was explanted due to infection.Subsequently, the local representative was informed that this patient had died on (b)(6), 2015.The cause of death was attributed to respiratory arrest.The patient's medical history was significant for severe sleep apnea.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: EASYTRAK 2
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4955942
• MDR Text Key: 6250901
• Report Number: 2124215-2015-10016
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012
• 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: 07/09/2015

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: 06/30/2012
• Device Model Number: 4518
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2010
• 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
• Treatment: 4470; 4518; 0158; 4136; N118
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR