MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Vomiting (2144); Dizziness (2194)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was having chronic vomiting, nausea, dizziness and orthostatic hypotension that is possibly related to the vns.During these episodes the patient feels like his brain is "banging around" in his head and he holds his head with his hands.The patient then vomits 20 times.The patient vomits when he moves his head.These episodes started with a frequency of once or twice a month and has increased to a couple of times a week.They started one month after implant and the relationship to vns stimulation was not known.These episodes are still occurring even though the patient is only implanted with the lead.The patient's generator was previously explanted as reported in mfg report #:1644487-2016-02184.The patient was hospitalized for the episodes.No root cause was found, but the patient's physician thought that it may be related to the vns lead.The patient was also referred to an infectious disease specialist to see if the symptoms are related to the infection reported to mfg report #:1644487-2016-02184.The patient was referred for lead explant.The patient's implant surgeon does not believe it is related to the vns lead.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

It was reported that the patient's neurologist strongly believed that the patient's symptoms were not related to vns or the implanted lead.The patient had a strong tilt-table test and had postural orthostatic tachycardia syndrome (pots) and the physician attributed his symptoms to this.The neurologist reported that the patient had a lot of issues.No additional relevant information has been received to date.No known intervention has occurred to date.

Manufacturer Narrative

Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.

Event Description

It was reported that the patient is no longer planned to undergo lead explant surgery due to the symptoms initially reported.Clinic notes dated (b)(6) 2016 reported that the patient was prescribed fludrocortisone for his dizziness.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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: 6091302
• MDR Text Key: 59556644
• Report Number: 1644487-2016-02583
• 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: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2019
• Device Model Number: 304-20
• Device Lot Number: 203690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2016
• 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): Hospitalization
• Patient Age: 8 YR