MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL UNKNOWN

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

Patient Problems Dyspnea (1816); Vomiting (2144); No Code Available (3191)

Event Date 05/29/2007

Event Type  Injury  

Event Description

It was reported that patient has had chronic vomiting since vns was implant.It was noted by the patient that a gastroenterologist stated the vns lead had possibly caused damaged to the esophagus and was the cause of the vomiting.The patient is looking to have the device removed due to the vomiting.The patient's generator is currently disabled.It was reported lead wire was observed to be protruding under the patient's neck skin.The patient was noted to have experienced dyspnea as well.The patient was noted to be looking for a surgeon to remove vns.The patient's neurologist from 2018 was unsure about the cause of the chronic vomiting and lead protrusion.It was noted by the neurologist that the gastroenterologist in his department believed the vomiting was related to vns based on the patient history.The patient was noted to have developed baro's esophagus due to the vomiting.No known surgery has occurred to date.No additional relevant information has been received.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11251725
• MDR Text Key: 229583482
• Report Number: 1644487-2021-00114
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/29/2021
• 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): Other
• Patient Age: 22 YR