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

Model Number G140

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

Patient Problems Death (1802); Pneumonia (2011); Sepsis (2067); Respiratory Failure (2484)

Event Date 01/20/2016

Event Type  Death  

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.

Event Description

Boston scientific received information that the patient was implanted with a cardiac resynchronization therapy defibrillator (crt-d) system on (b)(6) 2016.It was noted the patient was being treated with bactrim for cellulitis prior to the procedure.During the procedure, the physician was unable to successfully implant the left ventricular (lv) lead and the patient had epicardial leads placed later that day.Then the following day the patient went into respiratory failure.The patient never recovered.He developed sepsis and left lower lobe pneumonia.The patient was transferred to hospice care on (b)(6) and passed away the next day.The products have not been returned.

• Brand Name: INOGEN
• 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: 5445232
• MDR Text Key: 38493171
• Report Number: 2124215-2016-02923
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/22/2016

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: 02/18/2017
• Device Model Number: G140
• Other Device ID Number: INOGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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: 0693
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR