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

Model Number 4543

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

Patient Problems Bacterial Infection (1735); Embolism (1829); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067)

Event Date 03/31/2018

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

Boston scientific received information that this left ventricular (lv) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The lv lead was explanted.

Event Description

Additional information received indicates that seven days prior to the procedure the patient presented to the hospital and was admitted after receiving a shock from the cardiac resynchronization therapy defibrillator (crt-d).It was further noted that the patient was hypotensive and received intravenous fluids.The patient was also given a medication for ventricular tachycardia.The patient¿s blood cultures were positive for an infection and a foot ulcer was thought to be the source.Vegetation on the tricuspid valve and septic emboli to the lungs were observed.Due to the patient's worsening condition, the crt-d, right ventricular (rv) and left ventricular (lv) leads were explanted for infection.The right atrial (ra) lead was partially removed.No additional adverse patient effects were reported.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7622156
• MDR Text Key: 111773137
• Report Number: 2124215-2018-06856
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: 04/10/2016
• Device Model Number: 4543
• 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: 04/06/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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: 0293; 4470; 4543; N160
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR