MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problem Respiratory Distress (2045)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported the patient was hospitalized for a respiratory condition.During the patient's stay in the hospital, the pulmonologist told her that if the vns was removed, she would breathe better.However, the neurosurgeon and the epileptologist stated they disagreed with the pulmonologist and do not believe the patient's respiratory issue was related to vns.It is unknown why the neurosurgeon and the epileptologist believe the respiratory issue is not related to vns.The patient's vns was programmed off on (b)(6) 2015 and the patient will have a follow up appointment for an additional assessment.Attempts for additional information have been unsuccessful to date.

Event Description

Additional information was later received on (b)(6) 2016 that the patient was seen recently.Her vns is still off, and her seizures have increased.The patient has a scheduled emu stay for two weeks to assess her epilepsy.Per the neurologist, no further action will be taken with her until after the emu stay and recommendations are received.The patient as agreed to turn the vns back on if it is recommended.No additional relevant information has been received to date.

Event Description

The patient was seen by neurosurgery for patient request to have vns removed.The patient reported the device had been off and vns causes her pain and affects her breathing.The patient also needs a mri of the spine.No surgical intervention has occurred to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5331935
• MDR Text Key: 34575776
• Report Number: 1644487-2015-06852
• 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: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 105
• Device Lot Number: 203008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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: 34 YR