[Answered]: Instructions The following case studies are…

Instructions The following case studies are designed to assess your writing and critical thinking skills. Feel free to use any resources available to you to handle the situation below. Answer each of the questions below to the best of your ability. Cite any resources used to answer the questions. Once completed please return your responses to LivaNova. Case Study A parent has called LivaNova’s Neuromodulation Customer Quality (Clinical Technical Support) department to report that their child is doing very well with VNS, and the device has done a great job at reducing the frequency of the patient’s seizures. Recently, the child has been experiencing some hoarseness when she speaks, which the mother says is new for her. Please answer the following questions: 1. How would you handle the phone call? What questions would you ask the parent? What information would you provide? 2. Based on the information as reported, is there evidence that this is a report of a complaint? Discuss the rationale for your answer. 3. If this is considered a complaint, is it reportable (as an MDR) to the FDA? Discuss the rationale for your answer. 4. The objective of complaint investigations is to confirm the event and identify the cause. How would you investigate this complaint?