MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was experiencing a shortness of breath, voice hoarseness, and painful stimulation in the neck after initial implant surgery.The reported voice hoarseness occurred immediately after implant surgery and was slightly worse when the device was programmed to 0.25ma output current.The pain in the neck occurred with the patient was programmed on.The patient was reportedly programmed off immediately after surgery.In the first week of may, the patient had a tracheostomy due to the reported shortness of breath.It was also noted that the patient had a thyroid removed prior to vns implant surgery in (b)(6) and it was unclear if this surgery caused any of the symptoms.No additional relevant information has been received to date.

Event Description

Follow-up to the patient's treating physician revealed that the patient had post-operative bilateral vocal cord paralysis, prior to turning on the vns.Unilateral vocal cord paralysis was also suspected as a result of a prior thyroidectomy.The shortness of breath was reported to be attributable to vns implant surgery, and ultimately required tracheostomy.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• 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: 5707285
• MDR Text Key: 46854987
• Report Number: 1644487-2016-01282
• 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: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2017
• Device Model Number: 106
• Device Lot Number: 203667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• 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: 58 YR