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

Model Number 304-20

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Neck Pain (2433)

Event Date 04/22/2016

Event Type  Injury  

Event Description

A patient was reportedly experiencing neck pain with his vns device.Follow-up with the patient's neurologist stated that the patient's device had high impedance that showed the leads were reportedly disconnected.The physician stated that the patient's generator was disabled because the leads were "disconnected." the patient then underwent generator replacement, but the leas was not reportedly replaced.The surgeon who performed the replacement indicated that the reason for replacement was the neck pain.No further relevant information has been received to date.

Manufacturer Narrative

The initial emdr inadvertently did not include the information that the sales representative was notified of no lead issue.

Event Description

Updated information was received stating that the patient's vns device did not have pre-operative diagnostics performed.The patient's vns was off when interrogated prior to surgery.The surgeon did not perform any diagnostics before surgery.The physician did not report any issues with the lead to the representatives who covered the generator replacement surgery and the patient was reportedly undergoing the replacement only for the pain.

• 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: 6142200
• MDR Text Key: 61346805
• Report Number: 1644487-2016-02775
• 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: 11/08/2016

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: 10/23/2017
• Device Model Number: 304-20
• Device Lot Number: 202691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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