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

Model Number 304-20

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hearing Loss (1882); Pain (1994)

Event Date 10/30/2015

Event Type  Injury  

Event Description

It was reported that the patient was experiencing multiple adverse events.The patient felt throbbing pain in her left neck and significant pain/tenderness at the neck incision and up her neck to her ear for four days.She also reported that she could feel the "clamp" prominently under the incision when she touched her neck.The patient also felt painful stimulation for the past four days, and she had not felt stimulation up to that point.She had been having left ear pain/trouble hearing/feeling like her ear was "stopped up" for about four months, but the physicians did not identify any ear infections.The patient also felt pain in her chest, neck, and left shoulder for two to three days after her vns magnet was swiped.The patient had been feeling pain since she was implanted, but the pain had just recently gotten unbearable.The patient was taking pain medication four times a day, but that did not make the pain go away.The patient's ear hurt so badly that she could not let the wind hit it.The patient's treating physician believed that the surgeon had poor implant technique and the pain was related to the placement of the device.The physician did not know the cause of the pain during magnet swipes, and he didn't know if the hearing loss was related to vns or not.The patient was referred for surgery, and it was being done to preclude a serious injury as the patient was in excruciating pain that was getting worse.X-rays were ordered, but they have not been reviewed to date.No surgical intervention has occurred to date.

Event Description

The patient had full revision surgery.The generator was not sutured to the fascia, but was merely buried in subcutaneous tissue, which allowed for generator migration.The generator not being secured and the possible relationship to the pain experienced at the chest will be reported together in mfr.Report #1644487-2018-00847 as these issues now appear to be separate from the events in this report.The tie-downs were not sutured in place, and the surgeon noted that the electrodes were not properly coiled around the nerve.The explanting facility discards of product, so no evaluation could be performed on the devices.No further 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: 7373200
• MDR Text Key: 103548401
• Report Number: 1644487-2018-00463
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: 304-20
• Device Lot Number: 203363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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: 33 YR