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

Model Number 304-20

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Misfire (2532)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Seizures (2063); Discomfort (2330); Choking (2464); Electric Shock (2554)

Event Date 09/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2016 the physician indicated that the patient's chocking sensation is from misfiring of the vns.He said that the memory issues are not applicable.All diagnostics were reported to be within normal limits with the last one performed on (b)(6) 2016.The physician turned off the patient's vns and the patient is considering having it removed and probably not replaced.The patient does not have a medical history of these events prior to vns.The only event preceding the onset of the chocking/painful stimulation is replacement of the vns.It was previously reported that the patient underwent a full revision on (b)(6) 2014 due to issue following a mammogram.The patient is still having discomfort in the neck with stimulation, so the physician indicated that he would like contact information for a vns surgeon for another opinion as the previous surgeon stated he would not do another revision for the patient.It was reported that a system diagnostics test had not been performed after the recent complaint of painful stimulation.Additional information was requested from the physician but no further information was received regarding whether diagnostics were performed since the replacement.On (b)(6) 2016 the patient's mother reported that the patient has been experiencing painful stimulation as well as profound breathing issues since the generator revision.The breathing issues are described as a strong choking sensation leading to gasping and can last up to 30 seconds at a time.The patient then reported that this issue typically presents when she turns her head to the left or the right and that it has happened "thousands of times" so she is used to the effects.She also is experiencing memory issues.The patient stated that she is now having an increase in seizures since her device was turned off on (b)(6) 2016.She said that at this time, she wants her system replaced because of the shocking and not wanting to have the stimulation turned back on.The patient noted that the magnet is still programmed on.She then indicated that she never had a problem with the previous system and when it was turned on following replacement, she started to feel shocking that was more over the generator site in the shoulder.The issues were also indicated as not occurring with stimulation on-times but always happened and resolved when the generator was programmed off.The patient said that her phrenic nerve is being stimulated per her neurologist, but it wasn't clear how he determined this.She indicated that when the magnet was swiped the day after it was painful, which is why she doesn't want to turn it back on.The patient stated that there is no room on the nerve because the surgeon removed part of her vagus nerve and stitched it back together, which she was insistent that this occurred as the surgeon told her this.The patient said that the old system was completely removed according to the x-rays.On (b)(6) 2016, a physician reported that the patient was hospitalized due to the increased in seizures.He said the primary reason for disablement was painful stimulation, shocking in her neck that occurred when she turned her head.

Manufacturer Narrative

Inadvertently reported incorrect age on initial report.

Event Description

On 5/17/16 the physician reported that the patient did have a portion of their vagus nerve removed and then stitched back together again on (b)(6) 2014 during the full revision surgery that day.

• 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: 5498371
• MDR Text Key: 40246483
• Report Number: 1644487-2016-00544
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 304-20
• Device Lot Number: 3888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2014
• 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 Age: 32 YR