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

Model Number 304-20

Device Problems Detachment Of Device Component (1104); High impedance (1291)

Patient Problems Pain (1994); Seizures (2063); Fibrosis (3167); No Code Available (3191)

Event Date 10/18/2017

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on the patient's device through both normal mode diagnostics and system diagnostics.Follow-up with the physician found that the patient's lead wire had reportedly dislodged and the patient was experiencing a burning pain in their neck.The patient was also experiencing an increase in auras.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The treating neurologist indicated that they believed that the wire was dislodged because they could palpate it in the subcutaneous tissue.The patient's lead and generator were replaced.Product return is not expected.The replacement operative notes indicated that there was significant scar tissue in the patient's neck and it was unclear if a portion or the electrode was actually around the nerve.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: 7023835
• MDR Text Key: 92739880
• Report Number: 1644487-2017-04766
• 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
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: 304-20
• Device Lot Number: 3326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2012
• 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): Required Intervention
• Patient Age: 38 YR