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

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Seizures (2063); Tingling (2171); Dizziness (2194); Therapeutic Response, Decreased (2271)

Event Date 05/20/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced dizziness, tingling sensation in the fingers and increased perception of stimulation recently.Patient¿s dizziness and tingling sensation in the fingers were later reported to be possible partial seizures.Patient had gone to the er as she does not have a neurologist and the er nurse was informed about the magnet uses to disable the device.Additional information was received from the er nurse that the patient reported normally feeling stimulation from vns about twice a day.On (b)(6) 2015, the patient felt constant stimulation and experienced neck pain with stimulation.When magnet was taped to temporarily disable the vns, the pain was initially worse and then gone.However this repeated in a pattern where the pain was worse and then gone for a few minutes.Patient visited another hospital and the patient¿s generator was programmed off using the vns programmer.Since disablement of vns on (b)(6) 2015, patient did experience an increase in partial seizures due to loss of therapy.The patient was later seen by a nurse practitioner on (b)(6) 2015 and the vns was turned on to low settings of 0.5/30/250/30/5/0.75/60/500.Even at these settings, patient experienced coughing and voice hoarseness with stimulation and therefore medical professional decided to turn device off again and refer patient for vns replacement surgery.Diagnostics were performed and the impedance was within normal limits.The device was not at end of service.Chest x-rays were taken and no obvious issues were found.There was no trauma per patient prior to the events on (b)(6) 2015.Patient¿s previous vns settings prior to the reported events were unknown as the previous neurologist retired.No known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description

Additional notes from patient's visit to the hospital were received.On 5/20/2015, the patient reported that she will usually have 2 stimulations throughout the day, each lasting for approximately 30 seconds.But on (b)(6) 2015, patient reported a feeling of low frequency stimulation and also reports that she had one episode of higher frequency stimulation that lasted for approximately 2 minutes.No history of similar events in the past were reported.Patient denied any other changes to her health including increased seizure activity until (b)(6) 2015.Since patient had the vns implanted, patient's family felt her seizures were shorter in duration.Device diagnostics were completed on (b)(6) 2015 and lead impedance was ok and device was not near end of service.

• 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: 4840313
• MDR Text Key: 5936596
• Report Number: 1644487-2015-04885
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

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: 09/30/2010
• Device Model Number: 102
• Device Lot Number: 2202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2008
• 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: 23 YR