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

Model Number 302-20

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Dysphasia (2195); Respiratory Tract Infection (2420); Electric Shock (2554)

Event Date 01/15/2014

Event Type  Injury  

Event Description

It was reported by the ent physician that the vns patient was seen in his office on (b)(6) 2014.Clinic notes were from the office visit were received indicating that diagnostic flexible fiberoptic laryngoscopy revealed left vocal cord paralysis possibly from a displaced lead.The notes also indicated that the patient recently went to the er where ct showed left vocal cord paralysis.The patient was having severe pain in her left throat and pain when swallowing.The ent physician suggests that the pain may possibly be due to a displaced lead, and advised the patient to have her generator programmed off.Additional information was received from the patient stating that she had been experiencing severe pain and had taped her magnet over her generator to disable stimulation.Whenever the magnet shifted out of place, the patient reported that she experiences a shock and the pain worsens.The patient was seen by a surgeon to discuss vns replacement.The surgeon believes that the patient does not have vocal cord paralysis but has irregular spasmodic movement of her left vocal cord which followed a severe upper respiratory tract infection.The surgeon stated that the patient¿s symptoms seem to worsen with vns stimulation.The surgeon does not believe that the reported event requires surgery, but suggested lowering the patient¿s settings.While the surgeon believes that the reported event is not due to vns, the neurologist believes there is a relationship with the reported event and vns.As suggested by the surgeon, the neurologist lowered the patient¿s settings.Review of the available programming and diagnostic history for the device did not reveal any anomalies.

Event Description

The patient's device was programmed back on as there was no difference in the spasmodic dysphonia with or without vns stimulation.No further relevant information has been received to date.

• Brand Name: LEAD, MODEL 302
• 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: 3658670
• MDR Text Key: 4282836
• Report Number: 1644487-2014-00577
• 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: Health Professional,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

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: 03/31/2006
• Device Model Number: 302-20
• Device Lot Number: 010464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 03/04/2014
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2004
• 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): Required Intervention
• Patient Age: 39 YR