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

Model Number G148

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Pneumothorax (2012); Renal Failure (2041); Discomfort (2330)

Event Date 10/24/2015

Event Type  Injury  

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 this patient with a cardiac resynchronization therapy defibrillator (crt-d) device had clear chest x-ray result however, the patient was then admitted to the hospital again two days after implant procedure due to shortness of breath and chest discomfort.Ct-scan had showed that this patient had developed moderate to large pneumothorax and possible pneumonia.It was also documented that the patient also suffered from acute chronic renal insufficiency.The physician had performed an invasive intervention by placing a chest tube in the patient in order to mitigate the issue.The patient then had been recovering after given interventions were completed.This crt-d device remains in service.No additional adverse patient effects were reported.

• 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: 5414576
• MDR Text Key: 37615850
• Report Number: 2124215-2016-02239
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/24/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2017
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/24/2015
• Initial Date FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR