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

Model Number 304-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tingling (2171); Numbness (2415)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

Clinic notes were received that indicated on a recent visit on (b)(6) 2015 the patient complained that she was feeling tingling in her left neck, left elbow, and left little finger.She had her vns turned off because of these symptoms.The patient requested removal of the vns.Additional clinic notes were received which indicate that the patient feels the vns is not working for her.The patient reported numbness to the arm and feels like it is on fire.Good faith attempts for further information from the physician have been unsuccessful to date.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

(b)(4).Inadvertently did not include the udi on the initial report.

Event Description

On (b)(6) 2016 it was reported that the patient underwent explant of the vns on (b)(6) 2015.The explanted device was requested to be returned for product analysis but it was discarded by the hospital.

• 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: 5239410
• MDR Text Key: 31723186
• Report Number: 1644487-2015-06504
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2018
• Device Model Number: 304-20
• Device Lot Number: 4111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2016; 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR