MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Respiratory Distress (2045); Seizures (2063); Burning Sensation (2146); Dizziness (2194)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient was recently implanted with a new generator and he feels a burning sensation with magnet stimulation.There was no known trauma which could have caused or contributed to the burning sensation.It was mentioned that the physician should have the patient come in to have vns diagnostics checked.If everything was working as expected, the magnet settings could be adjusted to reduce the energy delivered.It was later reported the patient was seen on (b)(6) 2016 and the physician had adjusted his settings.The patient later called the physician's office complaining that he felt the vns turn on by itself several times, he felt dizzy, had shortness of breath, felt faint and would mumble after.He explained that he had 1 seizures on (b)(6) 2016 and 3 seizures at night on (b)(6) 2016.Attempts for additional relevant information have been unsuccessful to date.

Event Description

Additional information was received from one of the physician's offices and it was noted the patient had tried to swipe his magnet on (b)(6) 2016, but it did not work.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Date of event: this information was inadvertently left off of the initial mfr.Report.

Event Description

The physician's office later reported they had reached out to the patient and explained how the new vns device, which has autostimulation, worked.The patient stated he had not had any more issues with the device and now he knows it was just stimulating when he is having a seizure, and is not random.The patient is comfortable with the vns and believed it is working correctly and that he no longer feels he needs to have a physician look at the device at this time.The nurse confirmed that they do not feel there is anything wrong with the device and the symptoms he had were just stimulation related and he needed to acclimate to the new autostimulation.

• Brand Name: PULSE GEN MODEL 106
• 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: 6030381
• MDR Text Key: 57483659
• Report Number: 1644487-2016-02371
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2016

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: 09/10/2017
• Device Model Number: 106
• Device Lot Number: 4514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2016; 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• 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: 48 YR