MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 01/01/2013

Event Type  Injury  

Event Description

On (b)(6) 2014, it was reported that the generator site is "extremely" swollen (described as the size of a pocket with four generators inside), which has been like this for about a year.It was confirmed that the swelling was not normal.The patient also reports periodic swelling at the incision site in the neck.Normal mode diagnostics were performed with showed dcdc = 3.It was noted that the patient recently had an mri and it was not turned off during the procedure.At this time, the patient would like it resolved since she is getting efficacy and would prefer to not have the device explanted.Surgery is likely, but has not occurred to date.

Event Description

Additional information was received stating that the vns patient¿s swollen generator site was causing the patient to experience painful stimulation.No known surgical interventions have occurred to date.

Event Description

It was reported that the patient's the device was previously turned off due to painful stimulation.Explant may occur due to reasons unrelated to vns therapy.However, no known surgical interventions have occurred to date.

Event Description

The explanted generator and lead were received by the manufacturer for analysis.However, analysis has not been completed to date.

Event Description

Analysis was completed on the explanted products.In the pa lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.Analysis in the analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.Note that since a portion of the lead (including the electrode array) 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 anomalies were identified in the returned lead portion.

Event Description

It was reported that the patient's vns was explanted on (b)(6) 2015 due to the patient not wanting vns any longer and feeling that vns did not help her.Both the generator and majority of the lead was explanted.On (b)(6) 2015, the patient was doing well after explant.The nurse reported that the patient has a lot of psychiatric issues, so the patient thought vns was causing a lot of the problems.However, the nurse does not think that vns necessarily was and that it was likely more psych-related.The explanted devices have not been received by the manufacturer for analysis to date.Clinic notes dated (b)(6) 2015 reported that the presented to the clinic on (b)(6) 2014 with complaints of left shoulder and chest being "inflamed." she was advised to go to nearest er for evaluation but the patient declined.At that time, the patient was still wanting the vns settings to be adjusted.The neurologist assessed that since the patient had non-epileptic seizures, there was no plan to revise the vns.However, due to the patient's complaints, the decision was made to explant the vns.The patient reported redness and warmth over the left chest intermittently and typically applied an icepack to the area to relieve the symptoms.The patient stated that she had symptoms related to the vns when it is on, including throat tightness and right shoulder pain.However although the device was off, the patient still complained of difficulty swallowing at times with right arm pain and swelling.Therefore at that time, the surgeon assessed that the events very likely may have not been related to vns.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 3627213
• MDR Text Key: 4133305
• Report Number: 1644487-2014-00402
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,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: 10/31/2013
• Device Model Number: 102
• Device Lot Number: 3181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/21/2014; 07/15/2014; 01/22/2015; 03/16/2015; 03/27/2015; 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• 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; Required Intervention
• Patient Age: 28 YR