MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Scarring (2061); Fibrosis (3167); No Code Available (3191)

Event Date 10/03/2019

Event Type  malfunction  

Event Description

It was reported that the patient's vns device registered a high impedance reading prior to a vns replacement case.During surgery, the surgeon observed no tie downs were used at previous implant to secure the electrodes on the vagus nerve.It was noted that the electrodes were free to move about on the nerve a bit, and this caused a lot of torque and manipulation of the lead and the nerve itself.The surgeon identified a small fracture near the electrodes.Once the old generator and lead were explanted, the surgeon initially observed high impedance on the newly implanted vns system.After further review, the surgeon observed excessive scar tissue around the nerve, which the surgeon assessed was likely due to the electrodes manipulating the nerve over the course of the previous device¿s implant.The surgeon removed most of the scar tissue, including a large chunk that he sent for biopsy for possible neuroma, and then reattached the electrodes to the nerve.Then diagnostics were done three more times and each time they were good.The surgeon then completed the surgery and everything was normal.The explanted products were discarded, and therefore the generator and lead will not be returned for product analysis.Further follow up with the physician confirmed that the mass sent for biopsy tested positive for neuroma.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 9246027
• MDR Text Key: 164122647
• Report Number: 1644487-2019-02092
• 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
• Report Date: 10/28/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2016
• Device Model Number: 304-20
• Device Lot Number: 3305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2012
• 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): Other
• Patient Age: 16 YR