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

Model Number 106

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Pain (1994); Burning Sensation (2146); Shock from Patient Lead(s) (3162)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016 it was reported that the patient is having shocking from her vns.The vns was reported to be off and lead impedance ok with no recent magnet activations.The patient was referred for vns explant.Previously, on (b)(6) 2016 it was reported that the patient has a tingling sensation at the neck incision site.The patient was seen by the physician and is being considered for possible wound infection.The patient was seen for follow-up and no longer described any tingling or anything that was first reported.The patient reported having consistent burning sensation in the back of her head, and headaches and was concerned that it was being caused by vns.These events were not during stimulation cycle, but more on a consistent basis.All system diagnostics were ran, and came back ok.The physician said that her issues are not related to vns.The physician increased the patient's output current and magnet current by 0.125 each.On (b)(6) 2016 the physician reported she is still having pain and the only thing that the physician can attribute it to is vns.He has referred patient back to the surgeon, for vns explant.The patient saw the surgeon who also spoke with the neurologist and there has never been a time that there has been any issue showing with vns or diagnostics, and device had been turned off.The patient is still complaining of pain, and even though both physicians think it probably isn't related to vns, and is probably more than likely something different, the surgeon still wants to move forward and have the vns removed at the request of the patient.Apparently this patient has a past history of being a pain management patient.Although surgery is likely, it has not occurred to date.

Manufacturer Narrative

(b)(4).

Event Description

The patient underwent full system explant on (b)(6) 2016.The explanted devices have not been received for product analysis to date.

Event Description

The explanted lead and generator were received for product analysis on 5/16/16.Since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.Product analysis on the generator was also completed.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse condition found with the pulse generator.

• 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: 5567540
• MDR Text Key: 42412852
• Report Number: 1644487-2016-00768
• 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: 03/17/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 4623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/03/2016; 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 24 YR