MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Pain (1994)

Event Date 09/01/2017

Event Type  Injury  

Event Description

The patient reported that they were having difficulty swallowing, catching their breath, and felt some tightness in their throat.It was reported to first occur with magnet stimulation, and has been getting worse in the past six months.The patient stated that recently the difficulty swallowing, catching her breath and tightness in her throat is constant, and not only occurring with stimulation.The patient stated that they were hospitalized and an upper gi test was performed that came back negative.The patient has not seen a neurologist in some time and was questioning if her battery needed replacement.The patient does not have a current neurologist she visits.No other relevant information has been received to date.

Event Description

Additional information was received from the patient's previous neurologist who stated that the patient has not been seen since (b)(6) 2018, and the doctor no longer sees the patient.The device was not interrogated at this time, and there were not medication changes.The patient never mentioned any difficulty swallowing, shortness of breath or throat tightness to the neurologist.No other relevant information has been received to date.

Event Description

Additional information was received via clinic notes that this patient¿s primary care provider is concerned that the patient¿s throat cancer is returning as the patient has experienced throat pain and hoarseness.Patient reports symptoms have been worsening recently.Patient reports at first inability to tolerate solids and no difficulty tolerating liquids.Patient reports history of throat cancer 2007 when they were treated with surgery as well as chemotherapy.The notes also report that the patient was a former smoker.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7403911
• MDR Text Key: 104597914
• Report Number: 1644487-2018-00533
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

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: 12/13/2014
• Device Model Number: 103
• Device Lot Number: 3540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 05/02/2018; 07/31/2018
• Supplement Dates FDA Received: 05/16/2018; 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 50 YR