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 Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Date 10/01/2009

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 six months post implant the patient implanted with this product presented to the wound clinic with redness around pocket area with drainage.Surgical intervention was performed and the system was extracted.An allergy test later confirmed that the patient is allergic to chromium and nickle.There were no additional adverse effects 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6019181
• MDR Text Key: 57042443
• Report Number: 2124215-2016-12778
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• 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
• Report Date: 07/06/2016

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: 06/04/2010
• 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: 07/06/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2008
• 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: 0158; 4096; 4543; P107
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention