MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Emotional Changes (1831); Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271); Neck Pain (2433)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

It was later reported on (b)(6) 2015 that the patient was referred for explant surgery.Although surgery is likely, it has not occurred to date.The surgeon and the neurologist think that the patient is having mental issues that are causing the patient¿s problems, not the vns device.There have been multiple attempts to send the patient to psychology but the patient will not go.The patient is convinced the device is broken and wants a new one once his beliefs that the device is broken are confirmed, but the neurologist has concerns that this issue will be a recurrent one, as he believes the issue is psychological in nature, and therefore feels an explant is best.

Event Description

It was reported that the patient's generator and a portion of the lead were explanted on (b)(6) 2015 due to the patient no longer wanting vns.The explanted devices have not been received to date.

Event Description

The generator was returned for analysis on 05/07/2015, and is in progress.The lead assembly was returned for analysis and was completed on 05/22/2015.The connector ring has what appears to be pitting.Scanning electron microscopy images of the connector ring verified that pitting or electro-etching conditions have occurred on the connector¿s ring surface.Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once.The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector.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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description

Analysis was completed for the pulse generator on 06/10/2015.The septum was not returned and no evidence of body fluids was observed in the header septum cavity.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.There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description

It was reported that the patient started having pain in the left arm and neck that was bad enough for him to go to the emergency room on (b)(6) 2015.The patient¿s vns was then disabled and an x-ray taken to ensure that the lead had not been damaged.Once disabled, the pain initially felt a little better, but the shocking feeling continued after the device was turned off and still had some shocking sensations for the next 24-36 hours.The lead impedance was noted to have shown ¿ok¿ at the patient¿s appointment on (b)(6) 2015 and the patient was turned back on to the lowest possible settings without issue.When asked whether any trauma may have occurred to the lead, the patient admitted to being under the influence of marijuana and that he seemed to ¿loose time¿ and when he came to he was standing in his garage.A copy of the patient¿s x-ray review was received and it was noted that the generator was unable to be disabled with the magnet.The patient later stated that he woke up one day after some seizures and he started to feel really hard stimulations (almost euphorically).Patient said it gave him a good feeling and he was even having conversations with dead people.This went on for 2 days and the hard stimulations were, so overwhelming for him that he went to the emergency room.While he was in the waiting room, he started pushing on his device in his chest and then heard a pop.After that everything went back to normal.System diagnostics were performed on the patient's device again and everything was normal.The patient was referred to a surgeon.The patient reported that he attributes his hallucination and continuous stimulation to the vns.It was noted that the patient¿s device was disabled.

• Brand Name: PULSE GEN MODEL 105
• 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: 4501232
• MDR Text Key: 5458916
• Report Number: 1644487-2015-03794
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 105
• Device Lot Number: 202670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2013
• 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 Age: 36 YR