MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Insufficient Information (3190)

Patient Problem Paralysis (1997)

Event Type  Injury  

Event Description

The patient reported permanent vocal cord paralysis.The patient has not been evaluated for vocal cord paralysis, but did report to her currently treating physician that her vocal cord does work on the left side.The patient does have a medical history of unrelated health issues, such as fibromyalgia and laryngeal cancer.

Manufacturer Narrative

Brand name, corrected data: the initial report inadvertently reported the incorrect data.Model #, serial #, lot #, expiration date, corrected data: the initial report inadvertently reported the incorrect data.Device manufacture date, corrected data: the initial report inadvertently reported the incorrect data.

Event Description

On (b)(6) 2014, the nurse reported that the patient has vocal cord paralysis, but the patient has not been seen yet.Follow up with the physician found that the patient was supposed to bring in their old clinic notes to their appointment, but the patient was a no-show.No other information was provided.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 3627219
• MDR Text Key: 15234618
• Report Number: 1644487-2014-00403
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

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: 01/31/2006
• Device Model Number: 302-20
• Device Lot Number: 009946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2004
• 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