MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND AUTOGEN; IMPLANTABLE CHF GENERATOR

Model Number G177

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

Patient Problems Endocarditis (1834); Fever (1858); Staphylococcus Aureus (2058); Sepsis (2067)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

The research nurse provided the following update to the adverse event report.This patient was admitted to the hospital on (b)(6) 2015 with sepsis.The patient had a high fever and signs of erysipelas (a bacterial infection characterized by large, raised red patches on the skin) on the right foot.Blood cultures showed staphylococcus aureus.The patient was initially treated with rimactan and intravenous (iv) cefuroxime.The infection came from a venous ulcer on the patient¿s leg.Endocarditis was suspected but could not be verified on serial transoesophageal echocardiography (tees).On (b)(6) 2015, an intracardiac echocardiography was done.Intracardiac echocardiography did not find vegetation on the mechanical aortic valve; however, it did show vegetation on the ra lead (not on the rv lead as previously reported) in the superior vena cava.Physicians at the hospital decided on (b)(6) 2015 that it was too risky for the patient to undergo an explant procedure, as the patient would require re-implantation and would still be prone to infected foot ulcers.Iv antibiotics were stopped on (b)(6) 2015.The patient was discharged with life-long oral antibiotic treatment (moxifloxacin).The device and leads remain in service.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Clinical study: (b)(6).

Event Description

Boston scientific received information that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) system was diagnosed with device endocarditis.Vegetation was noted on a lead.The clinical study form did not indicate any intervention; however, the patient was hospitalized and it was suspected the patient was treated with intravenous antibiotics.Available information suggests the system remains implanted.A request was made for the field representative to obtain additional information from the study site.No additional adverse patient effects were reported.

• Brand Name: AUTOGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5788997
• MDR Text Key: 49369491
• Report Number: 2124215-2016-08353
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/2016
• Device Model Number: G177
• Other Device ID Number: AUTOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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: 1823
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention